PolyphenolsPOSTBIOTICSNCT06710106
Effect of a Low-calorie Diet With a Prebiotic Supplement on Health of Overweight-obese Subjects.
A study testing Prebiotic + hypocaloric diet in people with Polyphenols and Obesity, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The main objective of this project is to evaluate the effect of prebiotic supplementation on weight loss and other physiological and metabolic parameters related to excess weight in overweight/obese adult men and women, as well as to determine the changes in the gut microbiota associated with these changes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyphenols, Obesity, Weight Loss
- What is being tested?
- Prebiotic + hypocaloric diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2024to 23 May 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 70 years.
- Volunteers with overweight or obesity (BMI: 25.0-39.9 kg/m²) and body fat percentage > 30% for women / > 20% for men.
- Stable weight (+/- 5%) in the last three months prior to the start of the study.
- Normal physical examination and vital signs, or clinically insignificant findings for the experiment (those not related to metabolic health).
- Subjects must be able to understand and be willing to sign the informed consent form, agreeing to comply with all study procedures and requirements.
- Continued pharmacological/hormonal treatment will be allowed as long as it does not affect the study parameters and the dosage has been stable for at least 3 months. Exclusion will apply to treatments with insulin or any drug with hypoglycemic effects.
- Willingness to undergo each of the procedures involved in the study (including consuming a sweetened yogurt).
- Availability to attend the two in-person clinical evaluation sessions at the scheduled times and locations.
Who cannot join
- Volunteers undergoing pharmacological treatment if the treatment is not stable (at least 3 months before the start of the study), with exclusion of treatments:
- That alter gastrointestinal function.
- Stomach protectants.
- Hypoglycemic drugs.
- Insulin (under no circumstances).
- 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.
Show all 18Show fewer
- Subjects who have undergone surgical interventions with permanent sequelae in the digestive system (e.g., gastroduodenostomy) or bariatric surgery.
- Suffering from any chronic metabolic disease or obesity-related disease, or any systemic intestinal, liver, or kidney disease: type 1 or 2 diabetes, severe dyslipidemia, uncontrolled thyroid dysfunction, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (non-alcoholic fatty liver will not be an exclusion criterion).
- Exceeding the alcohol consumption limit for the corresponding sex (more than 14 units per week for women and 20 units per week for men).
- Pregnant, breastfeeding, or planning to become pregnant.
- Taking nutritional supplementation (weight loss supplements, fiber supplements, probiotics, multivitamins, etc.) that contains compounds that may affect the study outcomes, unless the person is willing to stop these supplements during the 8-week intervention period and ensures a minimum washout period of 30 days before baseline measurements.
- Having donated blood in the 14 days prior to the start visit.
- Subjects with any type of cancer or undergoing cancer treatment, or who have not been free of cancer for at least 5 years since eradication.
- Subjects with an allergy to any component of the study product or any other food that interferes with and complicates following the study protocol.
- Subjects with any cognitive and/or psychiatric impairment.
- Subjects who are expected to have poor cooperation or, in the investigator's opinion, have difficulty following the study procedures.
- Subjects currently undergoing treatment for weight loss/body composition modification.
- Subjects who are taking or have taken antibiotics within 30 days before the initial visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Low-calorie Diet With a Prebiotic Supplement on Health of Overweight-obese Subjects: a Randomized Controlled Trial
The main objective of this project is to evaluate the effect of prebiotic supplementation on weight loss and other physiological and metabolic parameters related to excess weight in overweight/obese adult men and women, as well as to determine the changes in the gut microbiota associated with these changes. Specific objectives are focus on evaluate the effect of the intervention on the following parameters:
- Weight and body composition.
- Changes in the gut microbiota (metagenomics).
- Changes in urinary and serum metabolites.
- Complete blood count, routine biochemical variables related to glucose and lipid metabolism, as well as liver health parameters.
- Specific markers involved in obesity pathology (insulin, leptin, adiponectin, and cytokines MCP1, TNF, CRP, and IL10).
- Satiety-related variables using a visual analog scale.
- Adherence to the assigned intervention, both to the hypocaloric diet and to the supplement provided in the study.
- Physical activity level.
- Changes in gastrointestinal health through self-reported questionnaires.
- Mental health and quality of life of participants through self-reported questionnaires.
- Chronotype of participants through a self-reported questionnaire. For this purpose, a randomized, double blind parallel study has been designed.
Read more
Target sample size is 156 subjects.
Participants will be allocated in two groups for 8 weeks:
- Experimental group (n=104): hypocaloric diet + prebiotic supplement.
- Placebo group (n=52): hypocaloric diet + placebo supplement.
Participants will visit nutritional intervention unit at week 1 and week 8. At week 4 they will receive a phone control call.
Read the detailed description
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend 2 Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 8 weeks. In both visits anthropometric and body composition measurements, blood pressure, stool and blood, urine and stool samples, as well as data about dietary, physical activity, sleep and gastrointestinal symptoms will be taken.
Inclusion criteria
- Men and women aged 18 to 70 years.
- Volunteers with overweight or obesity (BMI: 25.0-39.9 kg/m²) and body fat percentage > 30% for women / > 20% for men.
- Stable weight (+/- 5%) in the last three months prior to the start of the study.
- Normal physical examination and vital signs, or clinically insignificant findings for the experiment (those not related to metabolic health).
- Subjects must be able to understand and be willing to sign the informed consent form, agreeing to comply with all study procedures and requirements.
- Continued pharmacological/hormonal treatment will be allowed as long as it does not affect the study parameters and the dosage has been stable for at least 3 months. Exclusion will apply to treatments with insulin or any drug with hypoglycemic effects.
- Willingness to undergo each of the procedures involved in the study (including consuming a sweetened yogurt).
- Availability to attend the two in-person clinical evaluation sessions at the scheduled times and locations.
Exclusion criteria
- Volunteers undergoing pharmacological treatment if the treatment is not stable (at least 3 months before the start of the study), with exclusion of treatments:
- That alter gastrointestinal function.
- Stomach protectants.
- Hypoglycemic drugs.
- Insulin (under no circumstances).
- 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 who have undergone surgical interventions with permanent sequelae in the digestive system (e.g., gastroduodenostomy) or bariatric surgery.
- Suffering from any chronic metabolic disease or obesity-related disease, or any systemic intestinal, liver, or kidney disease: type 1 or 2 diabetes, severe dyslipidemia, uncontrolled thyroid dysfunction, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (non-alcoholic fatty liver will not be an exclusion criterion).
- Exceeding the alcohol consumption limit for the corresponding sex (more than 14 units per week for women and 20 units per week for men).
- Pregnant, breastfeeding, or planning to become pregnant.
- Taking nutritional supplementation (weight loss supplements, fiber supplements, probiotics, multivitamins, etc.) that contains compounds that may affect the study outcomes, unless the person is willing to stop these supplements during the 8-week intervention period and ensures a minimum washout period of 30 days before baseline measurements.
- Having donated blood in the 14 days prior to the start visit.
- Subjects with any type of cancer or undergoing cancer treatment, or who have not been free of cancer for at least 5 years since eradication.
- Subjects with an allergy to any component of the study product or any other food that interferes with and complicates following the study protocol.
- Subjects with any cognitive and/or psychiatric impairment.
- Subjects who are expected to have poor cooperation or, in the investigator's opinion, have difficulty following the study procedures.
- Subjects currently undergoing treatment for weight loss/body composition modification.
- Subjects who are taking or have taken antibiotics within 30 days before the initial visit.
- Conditions
- Polyphenols, Obesity, Weight Loss
- Being tested
- Prebiotic + hypocaloric diet, Placebo + hypocaloric diet
- Keywords
- supplement, obesity, polyphenols, prebiotic, microbiota
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic + hypocaloric dietDietary supplement
Study participants will add prebiotic formula in a natural yogurt every day to be consumed within a hypocaloric diet.
Placebo + hypocaloric dietDietary supplement
Study participants will add placebo formula in a natural yogurt every day to be consumed within a hypocaloric diet.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic group | Experimental | Natural yogurt with prebiotic formula Receives: Dietary Supplement: Prebiotic + hypocaloric diet |
| Placebo group | Placebo comparator | Natural yogurt with placebo formula Receives: Dietary Supplement: Placebo + hypocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiota
Fecal microbiota of participants will be analyzed by bacterial 16S or Shotgun gene sequencing technology.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Secondary outcomes (47)
Body weight
Weight of participants will be measured by bioimpedance and reported in kg
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Height
Height of participants will be measured by stadiometer and reported in m.
Measured: Clinical Investigation Day 1
Body mass index
Body mass index will be calculated as follows: weight (kilograms)/ height (cm)2
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body fat percentage
Body fat of participants will be analyzed by bioimpedance and reported in percentage and kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body muscle mass
Body muscle mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body lean mass
Body leen mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body water mass
Body water mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2.]
Body bone mass
Body bone mass of participants will be analyzed by bioimpedance and reported in kilograms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Gastrointestinal symptoms
Gastrointestinal symptoms will be registrated through Gastrointestinal Symptoms Rating Scale questionnaire, which is a questionnaire of 15 items. The questionnaire has a seven-point graded likert-type scale, where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Dietary intake
Dietary intake (energy, macronutrients and micronutrients) will be analysed by food frequency questionnaire.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Physical activity
Physical activity will be evaluated by the reduced version of the International Physical Activity Questionnaire, which estimates the total physical activity in MET-min/week, time spent sitting and classifies subjects based on their physical activity
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Adherence to capsule consumption
Adherence will be assessed using the capsule consumption record form.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Waist circumference
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Hip circumference
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Neck circumference
Neck circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: linical Investigation Day 1 and Clinical Investigation Day 2
Systolic blood pressure
Systolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Diastolic blood pressure
Diastolic blood pressure of participants in fasting condition will be analyzed by electronic tensiometer and reported in mmHg
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Heart rate
Heart rate of participants in fasting condition will be analyzed by electronic tensiometer and reported in pulses/min.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Glucose concentration
Blood glucose levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Insulin concentration
Blood insulin concentration will be analyzed after an overnight fast by ELISA kit.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Blood glycated hemoglobin
Fasting blood glycated hemoglobin will be reported in percentage.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
HOMA index
HOMA index will be calculated as follows: HOMA-IR = [fasting glucose (mmol/L) x fasting insulin (μU/ml)] / 22.5.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Total cholesterol
Blood total cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
HDL cholesterol
Blood HDL cholesterol levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
LDL cholesterol
LDL cholesterol levels of participants in fasting condition will be analyzed by Friedewald formula and reported in mg/dL.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Triglyceride concentration
Triglyceride levels of participants in fasting condition will be analyzed by biochemical autoanalyzer and reported in mg/dL.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Hemogram concentration
Hemogram levels of participants in fasting condition will be analyzed by biochemical autoanalyzer.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Leptine
Blood leptine concentration will be analyzed after an overnight fast by ELISA kit.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Adiponectin
Blood adiponectin concentration will be analyzed after an overnight fast by ELISA kit.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
MCP1
Blood MCP1 concentration will be analyzed after an overnight fast by ELISA kit.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Tumor necrosis factor alpha (TNF-alpha)
Blood TNF-alpha concentration will be analyzed after an overnight fast by ELISA kit.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
C Reactive protein (CRP)
Blood CRP concentration will be analyzed after an overnight fast by ELISA kit.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Interleukin 10 (IL10)
Blood IL10 concentration will be analyzed after an overnight fast by ELISA kit.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Albumin concentration
Albumin levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Creatinine concentration
Creatinine levels of participants in fasting condition will be analyzed in urine by biochemical autoanalyzer and reported in μmol/L.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Life quality
Life quality of participants will be evaluated by SF-36 questionnaire.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
chronotype
Morningness-Eveningness Questionnaire (MEQ)
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Level of hunger
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 is 100 mm. A reduction in hunger scale means better outcome.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Level of fullness
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: Clinical Investigation Day 1 and Clinical Investigation Day 2
Level of satisfaction
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: Clinical Investigation Day 1 and Clinical Investigation Day 2
Want to eat something else
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: Clinical Investigation Day 1 and Clinical Investigation Day 2
Thirst
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: Clinical Investigation Day 1 and Clinical Investigation Day 2
Blood untargeted metabolomics
Untargeted metabolomics will be analyzed in plasma and serum.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Urine untargeted metabolomics
Untargeted metabolomics will be analyzed in urine.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Lipidomic
Lipidomic will be analyzed in plasma and serum.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Depression
Depression will be evaluated by Beck questionnaire.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Anxiety
Anxiety will be evaluated by Stai questionnaire.
Measured: Clinical Investigation Day 1 and Clinical Investigation Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start13 Dec 2024
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyphenolsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel groups, blind, 8-week randomized nutritional intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Idoia Ibero, PhD, Study chair, Center for Nutrition ResearchMaría Hernández, Study chair, Center for Nutrition ResearchBlanca Martínez, Study chair, Center for Nutrition ResearchVerónica Ciaurriz, Study chair, Center for Nutrition ResearchCarlos González, PhD, Study chair, Center for Nutrition ResearchSalomé Pérez, Study chair, Center for Nutrition ResearchMarta Cuervo, PhD, Study chair, Center for Nutrition ResearchAna Lorente, Study chair, Center for Nutrition Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710106
- Sponsor's protocol ID
- POSTBIOTICS (2024.154)
- Acronym
- POSTBIOTICS
- Status last verified
- May 2025
- First submitted
- 25 Nov 2024
- Last updated
- 30 May 2025
- 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-calorie Diet With a Prebiotic Supplement on Health of Overweight-obese Subjects: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06710106
- Acronym / sponsor ID
- POSTBIOTICS / POSTBIOTICS (2024.154)
- Conditions
- Polyphenols, Obesity, Weight Loss
- Keywords
- supplement, obesity, polyphenols, prebiotic, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 29 Nov 2024 (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.
The main objective of this project is to evaluate the effect of prebiotic supplementation on weight loss and other physiological and metabolic parameters related to excess weight in overweight/obese adult men and women, as well as to determine the changes in the gut microbiota associated with these changes. Specific objectives are focus on evaluate the effect of the intervention on the following parameters:
- Weight and body composition.
- Changes in the gut microbiota (metagenomics).
- Changes in urinary and serum metabolites.
- Complete blood count, routine biochemical variables related to glucose and lipid metabolism, as well as liver health parameters.
- Specific markers involved in obesity pathology (insulin, leptin, adiponectin, and cytokines MCP1, TNF, CRP, and IL10).
- Satiety-related variables using a visual analog scale.
- Adherence to the assigned intervention, both to the hypocaloric diet and to the supplement provided in the study.
- Physical activity level.
- Changes in gastrointestinal health through self-reported questionnaires.
- Mental health and quality of life of participants through self-reported questionnaires.
- Chronotype of participants through a self-reported questionnaire. For this purpose, a randomized, double blind parallel study has been designed.
Target sample size is 156 subjects.
Participants will be allocated in two groups for 8 weeks:
- Experimental group (n=104): hypocaloric diet + prebiotic supplement.
- Placebo group (n=52): hypocaloric diet + placebo supplement.
Participants will visit nutritional intervention unit at week 1 and week 8. At week 4 they will receive a phone control call.
Detailed description
Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material.
During the intervention, volunteers will attend 2 Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 8 weeks. In both visits anthropometric and body composition measurements, blood pressure, stool and blood, urine and stool samples, as well as data about dietary, physical activity, sleep and gastrointestinal symptoms will be taken.
Inclusion criteria
- Men and women aged 18 to 70 years.
- Volunteers with overweight or obesity (BMI: 25.0-39.9 kg/m²) and body fat percentage > 30% for women / > 20% for men.
- Stable weight (+/- 5%) in the last three months prior to the start of the study.
- Normal physical examination and vital signs, or clinically insignificant findings for the experiment (those not related to metabolic health).
- Subjects must be able to understand and be willing to sign the informed consent form, agreeing to comply with all study procedures and requirements.
- Continued pharmacological/hormonal treatment will be allowed as long as it does not affect the study parameters and the dosage has been stable for at least 3 months. Exclusion will apply to treatments with insulin or any drug with hypoglycemic effects.
- Willingness to undergo each of the procedures involved in the study (including consuming a sweetened yogurt).
- Availability to attend the two in-person clinical evaluation sessions at the scheduled times and locations.
Exclusion criteria
- Volunteers undergoing pharmacological treatment if the treatment is not stable (at least 3 months before the start of the study), with exclusion of treatments:
- That alter gastrointestinal function.
- Stomach protectants.
- Hypoglycemic drugs.
- Insulin (under no circumstances).
- 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 who have undergone surgical interventions with permanent sequelae in the digestive system (e.g., gastroduodenostomy) or bariatric surgery.
- Suffering from any chronic metabolic disease or obesity-related disease, or any systemic intestinal, liver, or kidney disease: type 1 or 2 diabetes, severe dyslipidemia, uncontrolled thyroid dysfunction, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (non-alcoholic fatty liver will not be an exclusion criterion).
- Exceeding the alcohol consumption limit for the corresponding sex (more than 14 units per week for women and 20 units per week for men).
- Pregnant, breastfeeding, or planning to become pregnant.
- Taking nutritional supplementation (weight loss supplements, fiber supplements, probiotics, multivitamins, etc.) that contains compounds that may affect the study outcomes, unless the person is willing to stop these supplements during the 8-week intervention period and ensures a minimum washout period of 30 days before baseline measurements.
- Having donated blood in the 14 days prior to the start visit.
- Subjects with any type of cancer or undergoing cancer treatment, or who have not been free of cancer for at least 5 years since eradication.
- Subjects with an allergy to any component of the study product or any other food that interferes with and complicates following the study protocol.
- Subjects with any cognitive and/or psychiatric impairment.
- Subjects who are expected to have poor cooperation or, in the investigator's opinion, have difficulty following the study procedures.
- Subjects currently undergoing treatment for weight loss/body composition modification.
- Subjects who are taking or have taken antibiotics within 30 days before the initial visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel groups, blind, 8-week randomized nutritional intervention
| Arm | Type | Receives |
|---|---|---|
| Prebiotic group | Experimental | Dietary Supplement: Prebiotic + hypocaloric dietNatural yogurt with prebiotic formula |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo + hypocaloric dietNatural yogurt with placebo formula |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 18 to 70 years.
- Volunteers with overweight or obesity (BMI: 25.0-39.9 kg/m²) and body fat percentage > 30% for women / > 20% for men.
- Stable weight (+/- 5%) in the last three months prior to the start of the study.
- Normal physical examination and vital signs, or clinically insignificant findings for the experiment (those not related to metabolic health).
- Subjects must be able to understand and be willing to sign the informed consent form, agreeing to comply with all study procedures and requirements.
Key exclusion criteria (18 listed)
- Volunteers undergoing pharmacological treatment if the treatment is not stable (at least 3 months before the start of the study), with exclusion of treatments:
- That alter gastrointestinal function.
- Stomach protectants.
- Hypoglycemic drugs.
- Insulin (under no circumstances).
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 |
|---|---|---|
| Prebiotic + hypocaloric dietStudy participants will add prebiotic formula in a natural yogurt every day to be consumed within a hypocaloric diet. | Dietary supplement | Prebiotic group |
| Placebo + hypocaloric dietStudy participants will add placebo formula in a natural yogurt every day to be consumed within a hypocaloric diet. | Dietary supplement | Placebo group |
Primary outcome
Fecal microbiota
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Fecal microbiota of participants will be analyzed by bacterial 16S or Shotgun gene sequencing technology.
47 secondary outcomes
Body weight
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Height
Time frame: Clinical Investigation Day 1
Body mass index
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body fat percentage
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body muscle mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body lean mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Body water mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2.]
Body bone mass
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Gastrointestinal symptoms
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Dietary intake
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Physical activity
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Adherence to capsule consumption
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Waist circumference
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Hip circumference
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Neck circumference
Time frame: linical Investigation Day 1 and Clinical Investigation Day 2
Systolic blood pressure
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Diastolic blood pressure
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Heart rate
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Glucose concentration
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Insulin concentration
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Blood glycated hemoglobin
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
HOMA index
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Total cholesterol
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
HDL cholesterol
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
LDL cholesterol
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Triglyceride concentration
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Hemogram concentration
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Leptine
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Adiponectin
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
MCP1
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Tumor necrosis factor alpha (TNF-alpha)
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
C Reactive protein (CRP)
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Interleukin 10 (IL10)
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Albumin concentration
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Creatinine concentration
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Life quality
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
chronotype
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Level of hunger
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Level of fullness
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
Level of satisfaction
Time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2
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 30 May 2025.
- 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.
Idoia Ibero, PhD study chair
Center for Nutrition Research
María Hernández study chair
Center for Nutrition Research
Blanca Martínez study chair
Center for Nutrition Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic + hypocaloric diet in people with Polyphenols and Obesity, 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 8 inclusion and 18 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 30 May 2025. 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?
Fecal microbiota (time frame: Clinical Investigation Day 1 and Clinical Investigation Day 2). 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 30 May 2025.