ObesityCOLABOCONCT05368311

Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults

A study testing Dietary recommendations including protein enriched bars and Dietary recommendations without protein enriched bars in people with Obesity and Weight Loss, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Weight Loss, Protein
What is being tested?: Dietary recommendations including protein enriched bars and Dietary recommendations without protein enriched bars
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteSpain
Study dates: 13 Jan 2022to 30 Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Volunteers with BMI between 24.9 and 34.9 kg/m2.
Physical examination and vital signs normal or clinically irrelevant to the study.
Volunteers undergoing pharmacological treatment will be included if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function and antidiabetics.
Subjects must be able to understand and be willing to sign the informed consent, as well as comply with all the procedures and requirements of the study.
Present a stable weight (+/-3kg) in the last three months before the start of the study.

Who cannot join

Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
Women who are breastfeeding or pregnant.
Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
Subjects with liver disease.
Subjects with some type of cancer or undergoing treatment for it, or who have not had a period of at least 5 years since its eradication.

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Subjects with allergies to any component of the product under study or any other food that interferes and makes it difficult to monitor the study.
Subjects who present some type of cognitive and/or psychic impairment.
Subjects in whom poor collaboration is expected or who, in the opinion of the investigator, have difficulties in following the study procedures.
Subjects who work night shifts.
Subjects who follow some type of supplementation that interferes with the study.
Subjects who are immersed in some treatment for weight loss.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Center for Nutrition Research. University of Navarra
Pamplona, Navarre, 31008

Other trials in Spain

About this study

Obesity is considered the epidemic of the 21st century. Obesity is a multifactorial disease and the most important risk factors are poor diet and sedentary lifestyle. An excessive body weight contributes to increase the risk of suffering from other diseases and mortality rates. Therefore, the prevention and control of excessive body weight as well as its comorbidities are essential. In this sense, the principal strategy to treat obesity is to improve dietary habits and increase physical activity. However, the rate of obesity continues rising. In order to deal with this problem, new strategies to combat obesity are being investigated, such as the investigation of new bioactive compounds with satiating capacity that can be included in healthy dietary patterns to improve adherence to dietary treatments.

Considering this background, the main objective of this research is to assess the effect of daily consumption of protein rich bars accompanied by healthy dietary recommendations on weight loss of overweight/obese adult men and women.

Read the detailed description

This study is designed as a 12-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old.

All participants attend the Nutrition Intervention Unit of the Center for Nutrition Research in the University of Navarra for the screening visit and 4 more times during the intervention (week 1, 4, 8 and 12 of study).

Screening visit: evaluation of the inclusion criteria. Volunteers who meet the inclusion criteria are provided with a feces collection kit, urine collection kit, food frequency questionnaire, visual analogue scale and minnesota physical activity questionnaire. Moreover, they are randomly assigned to one of the two intervention groups:

Control group: healthy dietary recommendations.
Experimental group: healthy dietary recommendations + 2 protein rich bars/day

Clinical investigation day 1 (week 1): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in screening visit. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. After that, volunteer is provided with healthy dietary recommendations only or dietary recommendations and protein rich bars, depending on the allocated intervention group. Moreover, volunteer is provided with visual analogue scale to be completed for the Clinical investigation day 2.

Clinical investigation day 2 (week 4): The volunteer attend the Nutrition Intervention Unit. The volunteer is asked to provide the visual analogue scale. Then, gastrointestinal symptoms questionnaire is completed and the adherence to the study is assessed. Then, body weight and blood pressure are measured. Volunteer is provided with fece and urine collection kits, food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale, to be completed for the Clinical investigation day 3. Finally, volunteers allocated in experimental group are provided with protein rich bars.

Clinical investigation day 3 (week 8): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 2. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed. Volunteer is provided with fece and urine collection kits, as well as food frequency questionnaire, minnesota physical activity questionnaire and visual analogue scale to be completed for the Clinical investigation day 4. Finally, volunteers allocated in experimental group are provided with protein rich bars.

Clinical investigation day 4 (week 12): The volunteer attend the Nutrition Intervention Unit in fasting condition. Each volunteer is asked to provide the fece and urine samples, and completed questionnaires provided in Clinical investigation day 3. After that, the adherence to the study is assessed. Then, anthropometric, body composition, densitometry and blood pressure measurements are taken and the gastrointestinal symptoms questionnaire is completed.

Conditions: Obesity, Weight Loss, Protein
Being tested: Dietary recommendations including protein enriched bars, Dietary recommendations without protein enriched bars
Keywords: Protein, Weight loss, Obesity, Overweight, Satiety
Medical subject headings: Obesity, Weight Loss, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietary recommendations including protein enriched barsOther
Volunteers allocated in the experimental group will receive dietary recommendations and 2 protein enriched bars per day to be eaten 45 minutes before lunch and dinner.
Dietary recommendations without protein enriched barsOther
Volunteers allocated in the experimental group will receive dietary recommendations.

Study groups in NCT05368311
Study group	Role	What they receive
Group receiving dietary recommendations including protein enriched bars .	Experimental	Experimental group will consume two protein enriched bars per day during 12 weeks. First bar will be consumed 45 minutes before lunch and second bar will be consumed 45 minutes before dinner. Receives: Other: Dietary recommendations including protein enriched bars
Group receiving dietary recommendations without protein enriched bars.	Placebo comparator	Placebo group will follow just dietary recommendations during 12 weeks. Receives: Other: Dietary recommendations without protein enriched bars

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of weight from baseline to week 4 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of weight from baseline to week 8 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of weight from baseline to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of weight from week 4 to week 8 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 3(after 8 weeks of intervention).
Change of weight from week 4 to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of weight from week 8 to week 12 (bioimpedance)
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Secondary outcomes (158)

Change of body fat percentage from baseline to week 8 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat percentage from baseline to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat percentage from week 8 to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from baseline to week 8 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat kilograms from baseline to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from week 8 to week 12 (bioimpedance)
Body fat of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from baseline to week 8 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body muscle mass from baseline to week 12 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from week 8 to week 12 (bioimpedance)
Muscle mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from baseline to week 8 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body lean mass from baseline to week 12 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from week 8 to week 12 (bioimpedance)
Lean mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from baseline to week 8 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water mass from baseline to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from week 8 to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from baseline to week 8 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water percentage from baseline to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from week 8 to week 12 (bioimpedance)
Body water of participants in fasting condition will be analyzed by bioimpedance and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from baseline to week 8 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mass from baseline to week 12 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from week 8 to week 12 (bioimpedance)
Bone mass of participants in fasting condition will be analyzed by bioimpedance and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Height at baseline
Height of participants will be measured by stadiometer and reported in meters.
Measured: The Time Frame contains one time point: screening visit.
Change of waist circumference from baseline to week 8
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of waist circumference from baseline to week 12
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of waist circumference from week 8 to week 12
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from baseline to week 8
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hip circumference from baseline to week 12
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from week 8 to week 12
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from baseline to week 8
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of neck circumference from baseline to week 12
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from week 8 to week 12
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from baseline to week 4
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of systolic blood pressure from baseline to week 8
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from baseline to week 12
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from week 4 to week 8
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from week 8 to week 12
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from baseline to week 4
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of diastolic blood pressure from baseline to week 8
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of diastolic blood pressure from baseline to week 12
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from week 4 to week 8
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of diastolic blood pressure from week 8 to week 12
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of heart rate from baseline to week 4
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of heart rate from baseline to week 8
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of heart rate from baseline to week 12
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of heart rate from week 4 to week 8
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Measured: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of heart rate from week 8 to week 12
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in beats per minute.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in percentage from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat mass in percentage from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in percentage from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in percentage.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in kg from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat mass in kg from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat mass in kg from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from baseline to week 8 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of lean mass in kg from baseline to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from week 8 to week 12 (densitometry)
Change of body fat mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of lean mass in kg from baseline to week 12 (densitometry)
Change of lean mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral concentration from baseline to week 8 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral concentration from baseline to week 12 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral concentration from week 8 to week 12 (densitometry)
Change of bone mineral concentration of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density from baseline to week 8 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density from baseline to week 12 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density from week 8 to week 12 (densitometry)
Change of bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of visceral mass from baseline to week 8 (densitometry)
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of visceral mass from baseline to week 12 (densitometry)
Change of visceral mass density of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of visceral mass from week 8 to week 12 (densitometry)
Change of visceral mass of participants in fasting condition will be analyzed by densitometry machine and reported in kilograms.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of L1-L4 bone mineral density from baseline to week 8 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of L1-L4 bone mineral density from baseline to week 12 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of L1-L4 bone mineral density from week 8 to week 12 (densitometry)
Change of L1-L4 bone mineral density of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total bone mineral density of femur from baseline to week 8 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of total bone mineral density of femur from baseline to week 12 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total bone mineral density of femur from week 8 to week 12 (densitometry)
Change of bone mineral density of femur of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of femur neck from baseline to week 8 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density of femur neck from baseline to week 12 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of femur neck from week 8 to week 12 (densitometry)
Change of bone mineral density of femur neck of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of radius from baseline to week 8 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mineral density of radius from baseline to week 12 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mineral density of radius from week 8 to week 12 (densitometry)
Change of bone mineral density of radius of participants in fasting condition will be analyzed by densitometry machine and reported in g/m2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of glucose concentration from baseline to week 8
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of glucose concentration from baseline to week 12
Change of glucose levels of participants in fasting condition will be analyzed by absorptiometry and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of glucose concentration from week 8 to week 12
Change of glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total cholesterol concentration from baseline to week 8
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of total cholesterol concentration from baseline to week 12
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of total cholesterol concentration from week 8 to week 12
Change of total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of HDL cholesterol concentration from baseline to week 8
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of HDL cholesterol concentration from baseline to week 12
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of HDL cholesterol concentration from week 8 to week 12
Change of HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of LDL cholesterol concentration from baseline to week 8
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of LDL cholesterol concentration from baseline to week 12
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of LDL cholesterol concentration from week 8 to week 12
Change of LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of triglyceride concentration from baseline to week 8
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of triglyceride concentration from baseline to week 12
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of triglyceride concentration from week 8 to week 12
Change of triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of alanine aminotransferase concentration from baseline to week 8
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of alanine aminotransferase concentration from baseline to week 12
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of alanine aminotransferase concentration from week 8 to week 12
Change of alanine aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Measured: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of aspartate aminotransferase concentration from baseline to week 8
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of aspartate aminotransferase concentration from baseline to week 12
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of aspartate aminotransferase concentration from week 8 to week 12
Change of aspartate aminotransferase levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in U/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of homocysteine concentration from baseline to week 8
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of homocysteine concentration from baseline to week 12
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of homocysteine concentration from week 8 to week 12
Change of homocysteine levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in μmol/L..
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of C-reactive protein concentration from baseline to week 8
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of C-reactive protein concentration from baseline to week 12
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of C-reactive protein concentration from week 8 to week 12
Change of C-reactive protein levels of participants in fasting condition will be analyzed by ELISA and reported in mg/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hemogram concentration from baseline to week 8
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hemogram concentration from baseline to week 12
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hemogram concentration from week 8 to week 12
Change of hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of albumin concentration from baseline to week 8
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of albumin concentration from baseline to week 12
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of albumin concentration from week 8 to week 12
Change of albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of creatinine concentration from baseline to week 8
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 8 weeks of intervention).
Change of creatinine concentration from baseline to week 12
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of creatinine concentration from week 8 to week 12
Change of creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of physical activity level from baseline to week 8
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of physical activity level from baseline to week 12
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of physical activity level from week 8 to week 12
Change of physical activity level of participants will be analyzed by Minnesota physical activity questionnaire and reported in mets.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of dietary intake from baseline to week 8
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of dietary intake from baseline to week 12
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of dietary intake from week 8 to week 12
Change of dietary intake of participants will be analyzed by Food Frequency Questionnaire.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hunger from baseline to week 4
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale (VAS). The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of hunger from baseline to week 8
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hunger from baseline to week 12
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hunger from week 4 to week 8
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hunger from week 8 to week 12
The change in hunger of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in hunger scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of fullness from baseline to week 4
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of fullness from baseline to week 8
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of fullness from baseline to week 12
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of fullness from week 4 to week 8
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of fullness from week 8 to week 12
The change in fullness of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in fullness scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of satisfaction sensation from baseline to week 4
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of satisfaction sensation from baseline to week 8
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of satisfaction sensation from baseline to week 12
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of satisfaction sensation from week 4 to week 8
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of satisfaction sensation from week 8 to week 12
The change in satisfaction sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. An incrementation in satisfaction scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of want to eat something else sensation from baseline to week 4
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of want to eat something else sensation from baseline to week 8
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of want to eat something else sensation from baseline to week 12
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of want to eat something else sensation from week 4 to week 8
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of want to eat something else sensation from week 8 to week 12
The change in want to eat something else sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of thirst sensation from baseline to week 4
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in want to eat something else scale means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of thirst sensation from baseline to week 8
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of thirst sensation from baseline to week 12
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of thirst sensation from week 4 to week 8
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Measured: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of thirst sensation from week 8 to week 12
The change in thirst sensation of participants will be analyzed by Hunger-Satiety Visual Analogue Scale. The minimum value of the scale is 0 mm and the maximum value 100 mm.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 4
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 8
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 12
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of gastrointestinal symptoms from week 4 to week 8
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of gastrointestinal symptoms from week 8 to week 12
The change in gastrointestinal symptoms of participants will be analyzed by gastrointestinal symptoms questionnaire. The minimum value of the scale is 0 mm and the maximum value 100 mm. A reduction in the gastrointestinal symptoms means better outcome.
Measured: The Time Frame contains two time points: Clinical Investigation day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Bar acceptance at week 12
Bar acceptance will be analyzed by acceptance questionnaire.
Measured: The Time Frame contains Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bar consumption record from baseline to week 4
Change of bar consumption will be analyzed by bar consumption record.
Measured: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of bar consumption record from baseline to week 8
Change of bar consumption will be analyzed by bar consumption record.
Measured: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bar consumption record from baseline to week 12
Change of bar consumption will be analyzed by bar consumption record.
Measured: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bar consumption record from week 4 to week 8
Change of bar consumption will be analyzed by bar consumption record.
Measured: The Time Frame contains Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bar consumption record from week 8 to week 12
Change of bar consumption will be analyzed by bar consumption record.
Measured: The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change in urine and feces hydroxyproline concentration from baseline to week 8
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Measured: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change in urine and feces hydroxyproline concentration from baseline to week 12
Change of hydroxyproline concentration will be analyzed by colorimetry technique
Measured: The Time Frame contains Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change in urine and feces hydroxyproline concentration from week 8 to week 12
Change of hydroxyproline concentration will be analyzed at week 8 by colorimetry technique if significant differences are found in weight loss at week 8
Measured: The Time Frame contains Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202230 Aug 2022

First posted10 May 2022
Study start13 Jan 2022
Primary completion24 Jun 2022
Study completion30 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05368311
Sponsor's protocol ID: COLABOCO
Acronym: COLABOCO
Status last verified: Dec 2021
First submitted: 3 Mar 2022
Last updated: 12 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Protein Intake on Weight Loss of Overweight/Obese Adults
ClinicalTrials.gov ID: NCT05368311
Acronym / sponsor ID: COLABOCO / COLABOCO
Conditions: Obesity, Weight Loss, Protein
Keywords: Protein, Weight loss, Obesity, Overweight, Satiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
Study start: 13 Jan 2022 (actual)
Primary completion: 24 Jun 2022 (actual)
Study completion: 30 Aug 2022 (actual)
First posted: 10 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is designed as a 12-week, randomised, parallel study, focused on overweight/obese men and women between 20 and 65 years old.

Control group: healthy dietary recommendations.
Experimental group: healthy dietary recommendations + 2 protein rich bars/day

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group receiving dietary recommendations including protein enriched bars .	Experimental	Other: Dietary recommendations including protein enriched barsExperimental group will consume two protein enriched bars per day during 12 weeks. First bar will be consumed 45 minutes before lunch and second bar will be consumed 45 minutes before dinner.
Group receiving dietary recommendations without protein enriched bars.	Placebo comparator	Other: Dietary recommendations without protein enriched barsPlacebo group will follow just dietary recommendations during 12 weeks.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Volunteers with BMI between 24.9 and 34.9 kg/m2.
Physical examination and vital signs normal or clinically irrelevant to the study.
Volunteers undergoing pharmacological treatment will be included if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function and antidiabetics.
Subjects must be able to understand and be willing to sign the informed consent, as well as comply with all the procedures and requirements of the study.
Present a stable weight (+/-3kg) in the last three months before the start of the study.

Key exclusion criteria (12 listed)

Subjects with relevant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, reflux, etc.
Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
Women who are breastfeeding or pregnant.
Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
Subjects with liver disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dietary recommendations including protein enriched barsVolunteers allocated in the experimental group will receive dietary recommendations and 2 protein enriched bars per day to be eaten 45 minutes before lunch and dinner.	Other	Group receiving dietary recommendations including protein enriched bars .
Dietary recommendations without protein enriched barsVolunteers allocated in the experimental group will receive dietary recommendations.	Other	Group receiving dietary recommendations without protein enriched bars.

Primary outcome

Change of weight from baseline to week 4 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from week 4 to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 3(after 8 weeks of intervention).
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from week 4 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.
Change of weight from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 week of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Weight of participants in fasting condition will be analyzed by bioimpedance and reported in kg.

158 secondary outcomes

Change of body fat percentage from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat percentage from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat percentage from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body fat kilograms from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body fat kilograms from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body muscle mass from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body muscle mass from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body lean mass from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body lean mass from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water mass from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water mass from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of body water percentage from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of body water percentage from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from baseline to week 8 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of bone mass from baseline to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of bone mass from week 8 to week 12 (bioimpedance)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Height at baseline
Time frame: The Time Frame contains one time point: screening visit.
Change of waist circumference from baseline to week 8
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of waist circumference from baseline to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of waist circumference from week 8 to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from baseline to week 8
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of hip circumference from baseline to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of hip circumference from week 8 to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from baseline to week 8
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of neck circumference from baseline to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of neck circumference from week 8 to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from baseline to week 4
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of systolic blood pressure from baseline to week 8
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from baseline to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of systolic blood pressure from week 4 to week 8
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of systolic blood pressure from week 8 to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 3 (after 8 weeks of intervention) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from baseline to week 4
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).
Change of diastolic blood pressure from baseline to week 8
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).
Change of diastolic blood pressure from baseline to week 12
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 4 (after 12 weeks of intervention).
Change of diastolic blood pressure from week 4 to week 8
Time frame: The Time Frame contains two time points: Clinical Investigation Day 2 (after 4 weeks of intervention) compared to Clinical Investigation Day 3 (after 8 weeks of intervention).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

María Ángeles Zulet, Professor principal investigator

Center for Nutrition Research, University of Navarra.

Carlos J González Navarro, PhD study chair

Center for Nutrition Research, University of Navarra.

Fermín I Milagro Yoldi, PhD study chair

Center for Nutrition Research, University of Navarra.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of weight from baseline to week 4 (bioimpedance) (time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 4 weeks of intervention).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05368311.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.