OverweightNCT05394948
Circular Economy and the Design of Healthy and Sustainable Food and Ingredients
A study testing Dietary recommendations including experimental nutraceutic. in people with Overweight and Sustainability, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
There is a need to change eating patterns towards healthier diets with new sources of non-animal protein, obtained through more sustainable systems in line with strategies such as the European Green Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy, among others. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Sustainability, Food
- What is being tested?
- Dietary recommendations including experimental nutraceutic.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 30 Nov 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
- Age: 20-65 years.
- Body mass index: 25-29.9 kg/m2
- Physical examination and vital signs normal or clinically irrelevant to the experiment.
- Volunteers undergoing pharmacological treatment will be maintained if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function, antidiabetics and stomach protectors.
- Subjects must be able to understand and be willing to sign the informed consent, and must comply with all the procedures and requirements of the study.
- Subjects have to present a stable weight (+/-3kg) in the three months prior to 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 frecuent flatulence, diarrhea and intestinal discomfort.
- Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
- Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
- Women who are breastfeeding or pregnant.
- Subjects with liver disease.
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- 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.
- 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 follow some type of supplementation that interferes with the study: probiotics, supplements rich in fiber, laxatives, protein supplements, etc.
- Subjects who are immersed in some treatment for weight loss.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Navarra. Center for Nutrition Research.
Pamplona, Navarre, 31008
About this study
Official title: Design of Healthy and Sustainable Food and Ingredients Based on the Application of the Circular Economy
There is a need to change eating patterns towards healthier diets with new sources of non-animal protein, obtained through more sustainable systems in line with strategies such as the European Green Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy, among others.
The objective of this study, is to evaluate the nutritional effect of the developed products and their impact on the improvement and/or prevention of health problems (diabetes, intestinal dysbiosis), as well as to design and evaluation of the effect on health of a vegetable protein-based nutraceutical that also includes fiber and resistant starch.
Read the detailed description
This study is designed as a 3-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 2 times during the intervention (day 1 and day 21).
RECRUITMENT AND SCREENING:
The recruitment and screening of participants will be carried out through a Google Form questionnaire and by a phone call. At the same time, the database of people interested in participating in nutritional studies of the Center for Nutrition Research will be used, who will be contacted by phone or email to offer them the study. In addition, the study information and the recruitment form will also be posted on the Center for Nutrition Research website for anyone who wants to enroll in the study. On the other hand, the study will be disseminated through the channels available in the University of Navarra (Unclic, Alumni, emails, etc.) and through the placement of informative posters in the different buildings of the University of Navarra, as well as in public and private centers in Navarra, with prior authorization. If it is necessary, the study will be disseminated in the media such as in press, radio and TV.
The staff of the Nutritional Intervention Unit will assess the data provided by the potential participants and those who meet the inclusion criteria will be cited for the first visit of the study, which will take place in the Nutritional Intervention Unit of the Center for Nutrition Research in the University of Navarra. The information sheet and the informed consent will be sent to them beforehand so that they can read it for visit 1.
CLINICAL INVESTIGATION DAY 1 (day 1):
It will be carried out in groups of 10 people, who will attend the facilities of the University of Navarra fasting for at least 10 hours. The volunteers will be received by the nutritionist and the study nurse. Once gathered, proceed as follows:
- Welcome, detailed explanation of the study procedures and resolution of doubts.
- Delivery of the information sheet and the informed consents to the volunteers.
- Those volunteers who want to participate will sign the informed consent. Then, the procedures for taking samples and data will begin.
- Delivery of 2 kits for collecting stool samples (beginning and end). The sample collected at the beginning will be delivered within three days to the facilities of the Nutritional Intervention Unit.
- Delivery of a food consumption frequency questionnaire and a gastrointestinal symptoms questionnaire. They will be filled out with the help of the nutritionist during the visit and will refer to the last 3 weeks.
- Delivery of the VAS hunger-satiety questionnaire to be completed 1-2 days before the final visit.
- The dietician-nutritionist will take the anthropometric measurements of the volunteers individually and with light clothing.
- The nurse will draw blood (2 serum tubes of 5 mL).
- Delivery of the nutraceutical under study or the control nutraceutical (see composition in Table 1) as well as indications for the three weeks of the study. The nutraceutical should be consumed daily for 3 weeks as a substitute for breakfast in both groups.
- The date and time for the final visit (visit 2) will be specified.
CLINICAL INVESTIGATION DAY 2 (day 21):
It will be carried out in groups of 10 people, who will have to attend the University of Navarra fasting for at least 10 hours. The volunteers will be received by the nutritionist and the study nurse. Once gathered, proceed as follows:
- Collection of stool samples and VAS hunger-satiety questionnaire.
- General talk to welcome everyone and ask about the course of the 3 weeks.
- The dietitian-nutritionist will take the anthropometric measurements of the volunteers individually and with light clothing.
- The Food Frequency Questionnaire and the Gastrointestinal Symptoms Questionnaire corresponding to the final visit will be completed with the help of the nutritionist. They will refer to the 3 weeks that the intervention lasts.
- The volunteer will complete the Nutraceutical Acceptance Questionnaire.
- The nurse will draw blood (2 serum tubes of 5 mL).
- Conditions
- Overweight, Sustainability, Food, Microbiota, Habits
- Being tested
- Dietary recommendations including experimental nutraceutic., Dietary recommendations including control nutraceutic.
- Keywords
- Overweight, Microbiota, Sustainability, New food, Food ingredients
- Medical subject headings
- Overweight, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary recommendations including experimental nutraceutic.Dietary supplement
Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the experimental nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.
Dietary recommendations including control nutraceutic.Dietary supplement
Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the control nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group receiving dietary recommendations including experimental nutraceutic. | Experimental | Experimental group will consume experimental nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations. Receives: Dietary Supplement: Dietary recommendations including experimental nutraceutic. |
| Group receiving dietary recommendations including control nutraceutic. | Active comparator | Experimental group will consume control nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations. Receives: Dietary Supplement: Dietary recommendations including control nutraceutic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of fecal microbiota from baseline to week 3.
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Secondary outcomes (15)
Change of weight from baseline to week 3 (weighing machine)
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 3 weeks of intervention).
Change of body mass index from baseline to week 3.
Body mass index will be calculated as follows: weight (kg)/ height (cm)2.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 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: Clinical Investigation Day 1 (at baseline).
Change of waist circumference from baseline to week 3.
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 2 (after 3 weeks of intervention).
Change of glucose concentration from baseline to week 3.
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 2 (after 3 weeks of intervention).
Change of insulin concentration from baseline to week 3.
Change of insulin levels of participants in fasting condition will be analyzed by ELISA kit and reported in mU/L.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of HOMA index from baseline to week 3.
Change of HOMA index of participants in fasting condition will be calculated by the following formula: insulin (μU/ml) x glucose (mmol/l)/22,5.
Measured: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of dietary intake from baseline to week 3.
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 2 (after 3 weeks of intervention).
Change of hunger from baseline to week 3.
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 3 weeks of intervention).
Change of fullness from baseline to week 3.
The change in fullness 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 3 weeks of intervention).
Change of satisfaction from baseline to week 3.
The change in satisfaction 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 3 weeks of intervention).
Change of want to eat something else sensation from baseline to week 3.
The change in want to eat something else sensation 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 3 weeks of intervention).
Change of thirst from baseline to week 3.
The change in thirst 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 3 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 3.
Gastrointestinal symptoms will be analyzed by a gastrointestinal symptom questionnaire.
Measured: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Nutraceutical acceptance at week 3.
Nutraceutical acceptance will be analyzed by acceptance questionnaire.
Measured: The Time Frame contains Clinical Investigation Day 2 (after 3 weeks of intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Oct 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fermín I Milagro Yoldi, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394948
- Sponsor's protocol ID
- ALISSEC
- Status last verified
- Jan 2023
- First submitted
- 23 May 2022
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of Healthy and Sustainable Food and Ingredients Based on the Application of the Circular Economy
- ClinicalTrials.gov ID
- NCT05394948
- Acronym / sponsor ID
- ALISSEC
- Conditions
- Overweight, Sustainability, Food, Microbiota, Habits
- Keywords
- Overweight, Microbiota, Sustainability, New food, Food ingredients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 27 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.
There is a need to change eating patterns towards healthier diets with new sources of non-animal protein, obtained through more sustainable systems in line with strategies such as the European Green Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy, among others.
The objective of this study, is to evaluate the nutritional effect of the developed products and their impact on the improvement and/or prevention of health problems (diabetes, intestinal dysbiosis), as well as to design and evaluation of the effect on health of a vegetable protein-based nutraceutical that also includes fiber and resistant starch.
Detailed description
This study is designed as a 3-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 2 times during the intervention (day 1 and day 21).
RECRUITMENT AND SCREENING:
The recruitment and screening of participants will be carried out through a Google Form questionnaire and by a phone call. At the same time, the database of people interested in participating in nutritional studies of the Center for Nutrition Research will be used, who will be contacted by phone or email to offer them the study. In addition, the study information and the recruitment form will also be posted on the Center for Nutrition Research website for anyone who wants to enroll in the study. On the other hand, the study will be disseminated through the channels available in the University of Navarra (Unclic, Alumni, emails, etc.) and through the placement of informative posters in the different buildings of the University of Navarra, as well as in public and private centers in Navarra, with prior authorization. If it is necessary, the study will be disseminated in the media such as in press, radio and TV.
The staff of the Nutritional Intervention Unit will assess the data provided by the potential participants and those who meet the inclusion criteria will be cited for the first visit of the study, which will take place in the Nutritional Intervention Unit of the Center for Nutrition Research in the University of Navarra. The information sheet and the informed consent will be sent to them beforehand so that they can read it for visit 1.
CLINICAL INVESTIGATION DAY 1 (day 1):
It will be carried out in groups of 10 people, who will attend the facilities of the University of Navarra fasting for at least 10 hours. The volunteers will be received by the nutritionist and the study nurse. Once gathered, proceed as follows:
- Welcome, detailed explanation of the study procedures and resolution of doubts.
- Delivery of the information sheet and the informed consents to the volunteers.
- Those volunteers who want to participate will sign the informed consent. Then, the procedures for taking samples and data will begin.
- Delivery of 2 kits for collecting stool samples (beginning and end). The sample collected at the beginning will be delivered within three days to the facilities of the Nutritional Intervention Unit.
- Delivery of a food consumption frequency questionnaire and a gastrointestinal symptoms questionnaire. They will be filled out with the help of the nutritionist during the visit and will refer to the last 3 weeks.
- Delivery of the VAS hunger-satiety questionnaire to be completed 1-2 days before the final visit.
- The dietician-nutritionist will take the anthropometric measurements of the volunteers individually and with light clothing.
- The nurse will draw blood (2 serum tubes of 5 mL).
- Delivery of the nutraceutical under study or the control nutraceutical (see composition in Table 1) as well as indications for the three weeks of the study. The nutraceutical should be consumed daily for 3 weeks as a substitute for breakfast in both groups.
- The date and time for the final visit (visit 2) will be specified.
CLINICAL INVESTIGATION DAY 2 (day 21):
It will be carried out in groups of 10 people, who will have to attend the University of Navarra fasting for at least 10 hours. The volunteers will be received by the nutritionist and the study nurse. Once gathered, proceed as follows:
- Collection of stool samples and VAS hunger-satiety questionnaire.
- General talk to welcome everyone and ask about the course of the 3 weeks.
- The dietitian-nutritionist will take the anthropometric measurements of the volunteers individually and with light clothing.
- The Food Frequency Questionnaire and the Gastrointestinal Symptoms Questionnaire corresponding to the final visit will be completed with the help of the nutritionist. They will refer to the 3 weeks that the intervention lasts.
- The volunteer will complete the Nutraceutical Acceptance Questionnaire.
- The nurse will draw blood (2 serum tubes of 5 mL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group receiving dietary recommendations including experimental nutraceutic. | Experimental | Dietary Supplement: Dietary recommendations including experimental nutraceutic.Experimental group will consume experimental nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations. |
| Group receiving dietary recommendations including control nutraceutic. | Active comparator | Dietary Supplement: Dietary recommendations including control nutraceutic.Experimental group will consume control nutraceutic instead of the habitual breakfast during 3 weeks and within a dietary recommendations. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 20-65 years.
- Body mass index: 25-29.9 kg/m2
- Physical examination and vital signs normal or clinically irrelevant to the experiment.
- Volunteers undergoing pharmacological treatment will be maintained if the dose is stable for at least 3 months before the start of the study, excluding treatments that alter gastrointestinal function, antidiabetics and stomach protectors.
- Subjects must be able to understand and be willing to sign the informed consent, and must comply with all the procedures and requirements 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 frecuent flatulence, diarrhea and intestinal discomfort.
- Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (for example, gastroduodenostomy).
- Subjects with a high alcohol intake, more than 14 units (women) and 20 units (men).
- Women who are breastfeeding or pregnant.
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 experimental nutraceutic.Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the experimental nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention. | Dietary supplement | Group receiving dietary recommendations including experimental nutraceutic. |
| Dietary recommendations including control nutraceutic.Volunteers allocated in the control group will receive every day and during 3 consecutive weeks the control nutraceutic instead of the breakfast. Nutraceutical intake will be accompanied by nutritional advice to follow for the 3 weeks of intervention. | Dietary supplement | Group receiving dietary recommendations including control nutraceutic. |
Primary outcome
Change of fecal microbiota from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Fecal microbiota of participants will be analyzed by bacterial 16S gene sequencing technology.
15 secondary outcomes
Change of weight from baseline to week 3 (weighing machine)
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of body mass index from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Height at baseline.
Time frame: The Time Frame contains one time point: Clinical Investigation Day 1 (at baseline).
Change of waist circumference from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of glucose concentration from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of insulin concentration from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of HOMA index from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of dietary intake from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of hunger from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of fullness from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of satisfaction from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of want to eat something else sensation from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of thirst from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Change of gastrointestinal symptoms from baseline to week 3.
Time frame: The Time Frame contains two time points: Clinical Investigation day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).
Nutraceutical acceptance at week 3.
Time frame: The Time Frame contains Clinical Investigation Day 2 (after 3 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 23 May 2024.
- 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.
Fermín I Milagro Yoldi, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary recommendations including experimental nutraceutic. in people with Overweight and Sustainability, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 6 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 23 May 2024. 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. 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 fecal microbiota from baseline to week 3. (time frame: The Time Frame contains two time points: Clinical Investigation Day 1 (at baseline) compared to Clinical Investigation Day 2 (after 3 weeks of intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2024.