Obesity and OverweightPREDIET-ARACNCT06911346
Plant-Based Foods and (Poly)Phenol Supplementation in Gut Microbiota Modulation, Body Weight, and Cardiometabolic Risk
A study testing Diet supplementation and Polyphenol-rich supplement in people with Obesity and Overweight, run by Universidad Catolica de Temuco at 1 site in Chile.
Trial summary
This single-blind, randomized controlled trial aims to evaluate the effects of increased dietary polyphenol intake-either through a healthy plant-based diet (PBD) or supplementation-on body weight and cardiometabolic risk factors in adults with overweight or obesity. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Diet supplementation and Polyphenol-rich supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 21 Jul 2025to 3 Aug 2026
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 25 and 45 years (adult)
- Sexes: All
- Overweight or obesity class I (BMI 25-35 kg/m²)
- At least three of the following cardiometabolic risk factors:
- Current smoker (more than 1 cigarette per day during the last month) Sitting time greater than 7 hours per day or classified as inactive according to the IPAQ Fasting glucose ≥100 mg/dL (5.6 mmol/L)
- High blood pressure:
Show all 11Show fewer
- Systolic blood pressure >130 mmHg Diastolic blood pressure >85 mmHg High serum triglycerides (≥150 mg/dL) HbA1c ≥38 mmol/mol (>5.7%)
- Waist circumference defined by Peterman et al. for the Chilean population:
- 92.3 cm for men 87.6 cm for women High high-sensitivity C-reactive protein (hs-CRP) (≥2.0 mg/L)
- Family history of premature coronary heart disease:
- Definite myocardial infarction or sudden death before age 55 in father or male first-degree relative Before age 65 in mother or female first-degree relative
Who cannot join
- Presence of cardiovascular disease, diabetes, or hypertension
- Severe medical conditions that may impair participation in a nutrition intervention study (e.g., digestive disease, advanced malignancy, major neurological or psychiatric disease)
- Any medical condition limiting survival to less than one year
- Illegal drug use, chronic alcoholism, or problematic alcohol use
- BMI ≥35 kg/m²
- Antibiotic use within the last month
- Low predicted likelihood of changing dietary habits according to the Prochaska and DiClemente stages of change model
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Role of Native Plant-Based Foods and (Poly)Phenol Supplementation in Modifying Gut-Microbiota Metabolism: A Strategy for Reducing Body Weight and Cardiometabolic Risk
This single-blind, randomized controlled trial aims to evaluate the effects of increased dietary polyphenol intake-either through a healthy plant-based diet (PBD) or supplementation-on body weight and cardiometabolic risk factors in adults with overweight or obesity.
A total of 99 participants (aged 25-45 years, BMI 25-35 kg/m²) with cardiovascular risk factors will be recruited from local health centers and randomly assigned (1:1:1) to one of three intervention groups for 12 weeks: (1) a healthy PBD rich in polyphenols, with supplemental apple, blueberries, hazelnuts, extra-virgin olive oil, and coffee provided at no cost to the participant (2) a healthy diet plus polyphenol supplementation (≈30g/day) from maqui , green tea, olive leaf, cranberry, and grape extracts, or (3) a control group receiving placebo and standard healthy diet recommendations. All groups will follow a caloric deficit.
Read more
Dietary intake will be assessed using three 24-hour dietary recalls at baseline and 12 weeks, with polyphenol intake estimated via the Phenol-Explorer database. Data collection will include lifestyle questionnaires, anthropometric and bioimpedance measurements, blood pressure assessments, physical activity monitoring via accelerometers, and strength evaluations. Blood samples will be analyzed using a large-scale targeted metabolomics approach (UHPLC-MS/MS) to identify metabolic signatures, particularly those linked to gut microbiota. Faecal samples will be collected at baseline and visit 3.
Findings will provide insights into how dietary polyphenols-either from whole foods or supplementation-affect obesity-related outcomes and cardiometabolic risk, potentially unveiling gut microbial biomarkers as future therapeutic targets. This study aims to contribute to strategies for obesity and cardiometabolic risk prevention and treatment.
Read the detailed description
The primary objective of this study is to evaluate the impact of increased dietary polyphenol intake-either through a healthy plant-based diet (PBD) or supplementation-on body weight and cardiometabolic risk factors in adults with overweight or obesity. Additionally, the study seeks to explore the role of gut-microbiota-derived metabolites as potential mediators of these effects through metabolomic analyses.
The calculation determined a required sample size of 90 participants. To account for potential dropouts, a 10% buffer was added, resulting in a final target of 99 participants (33 per group); trial power of 0.8 and alfa error of 5%. A total of 99 participants (aged 25-45 years, BMI 25-35 kg/m²) with at least three cardiometabolic risk factors will be recruited from Health Centers supported by the Health Department of the Municipality in Temuco, Chile.
Participants will be randomly assigned (stratified by sex and age: <35y and ≥35y) in a 1:1:1 ratio to one of three groups for a 12-week intervention, with assessments conducted at baseline, week 6, and week 12:(1) a group following a healthy PBD rich in polyphenols, (2) a group following a healthy diet plus polyphenol supplementation (≈30g/day from maqui, green tea, cranberry, olive leaf and grape extracts), and (3) a control group receiving placebo and standard dietary recommendations. All groups will follow a caloric deficit (~1,200 kcal/day) for the entire 12-week study. This will be explained to each participant during the first visit.
Dietary data will be collected using three 24-hour dietary recalls at baseline and after 12 weeks, employing the SER 24 HDR software. The SER-24H software (University of Chile; Santiago, Chile) developed by CIAPEC (Center for Research in Food Environments and Prevention of Nutrition-Associated Diseases) at INTA, University of Chile, was used for dietary assessment. The Phenol-Explorer database estimates dietary polyphenol intake. It is the first comprehensive database on polyphenol content in foods. It contains more than 35,000 content values for 500 different polyphenols in over 400 foods.
Lifestyle, general health, and physical activity will be assessed through validated questionnaires. Anthropometric and body composition measurements will be taken using bioimpedance analysis. Blood pressure will be monitored with sphygmomanometers, while muscle strength will be measured via dynamometry.
Biological samples, including blood and plasma, will be collected at baseline and after 12 weeks. On each visit, 20ml of blood will be extracted from the antecubital vein and will be centrifuged and stored at -80ºC in the ultra-freezers of the School of Medicine at the Catholic University of Temuco until used.
Additionally, participants will be invited to provide a faecal sample during the first and third visits. These samples are not part of the main study but will be stored at -80ºC for potential future microbiota analyses (School of Medicine at the Catholic University of Temuco).
Biochemical analyses will be performed by institutional laboratory. Blood tests will include rutinary hematology and biochemistry, and inflammatory parameters.
Targeted metabolomic analyses will be conducted using ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UHPLC-MS/MS) to identify and quantify polyphenol-derived metabolites, gut microbial metabolites, and other biochemical markers relevant to obesity and cardiometabolic risk.
Participants in the PBD group will receive a structured dietary plan featuring regional and national polyphenol-rich foods such as blueberries, hazelnuts, olive oil, apples, and coffee. The polyphenol supplementation group will receive a standardized supplement taken twice daily. The control group will receive placebo and standard nutritional counseling.
The study will adhere to ethical guidelines, including the Declaration of Helsinki and Good Clinical Practice principles. Ethical approval will be obtained, and all participants will provide informed consent. Data privacy will be ensured in compliance with applicable regulations.
Statistical analyses will be conducted on an intention-to-treat and per-protocol basis. Primary outcomes include changes in body weight and body composition, while secondary outcomes focus on cardiometabolic risk factors, dietary adherence, and metabolic signatures identified through metabolomics. Differences between pre- and post-intervention data, as well as between groups, will be analyzed using multivariate models, machine-learning algorithms, and generalized linear mixed models (GLMMs).
- Conditions
- Obesity and Overweight
- Being tested
- Diet supplementation, Polyphenol-rich supplement, Placebo
- Keywords
- Plant-Based Diet, Polyphenol Supplementation, Cardiometabolic Risk, Weight Loss, Gut Microbiota
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet supplementationDietary supplement
Healthy plant-based diet (plus supplemental foods) as part of a hypocaloric diet.
Polyphenol-rich supplementDietary supplement
Hypocaloric diet with polyphenol-rich supplement. Polyphenol-rich sachets containing ≈30g/day of a combination of plant extracts rich in polyphenol. Frequency: 2 sachets a day. Duration: 12 weeks
PlaceboOther
Hypocaloric diet plus Placebo. The placebo is a sachet (≈30g/day) with similar appearance, taste, and texture but without active polyphenols. Frequency: 2 sachets a day. Duration: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplementation Group | Experimental | Healthy plant-based diet (plus supplemental foods) as part of a hypocaloric diet. Receives: Dietary Supplement: Diet supplementation |
| Polyphenol-rich Supplement Group | Experimental | Hypocaloric diet with polyphenol-rich supplement. Receives: Dietary Supplement: Polyphenol-rich supplement |
| Placebo Control Group | Placebo comparator | Hypocaloric diet plus Placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Unit: Kilograms Measured with: bioimpedance scan
Measured: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Secondary outcomes (29)
Systolic blood pressure
Unit: mmHg Measured with: Sphygmomanometer
Measured: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Diastolic blood pressure
Unit: mmHg Measured with: Sphygmomanometer
Measured: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Glucose
Plasma concentrations (mg/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Glycosylated hemoglobin
Measured through plasma concentrations Unit: %
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Insulin
Measured through plasma concentrations Unit/ml
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Triglycerides
Plasma concentrations (mg/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
HDL (high-density lipoprotein)-cholesterol
Plasma concentrations (mg/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
LDL (low-density lipoprotein)-cholesterol
Plasma concentrations (mg/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Total cholesterol
Plasma concentrations (mg/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Waist circumference
Unit: centimetres Measured with: ergonomic measuring tape
Measured: Visit 1 (baseline), visit 2 (week 6), visit 3 (week 12)
Hip circumference
Unit: centimetres Measured with: ergonomic measuring tape
Measured: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Fat mass
Unit: % Measured with: bioimpedance scan
Measured: Visit 1 (baseline), visit 2 (week 6), visit 3 (week 12)
Muscle mass
Unit: % Measured with: bioimpedance scan
Measured: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Alanine aminotransferase
Measured through plasma concentrations: Unit: units/litre
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Aspartate aminotransferase
Measured through plasma concentrations Units: units/litre
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Bilirrubin
Measured through plasma concentrations Unit: mg/dl
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Creatinin
Measured through plasma concentrations (mg/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Urea
Measured through plasma concentrations (mg/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Uric acid
Measured through plasma concentrations Unit: mg/dl
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Hemoglobin
Plasma concentrations (g/dl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Erithrocytes
Plasma concentrations (cel/mcl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Leucocytes
Plasma concentrations (cel/mcl)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Thyroid-stimulating hormone (TSH)
Measured through plasma concentrations (mU/litre)
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Dietary intake
24-h dietary recall and food frequency questionnaire
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Physical activity level
Unit: MET-min per week Measured with: International Physical Activity Questionnaire (IPAQ)
Low: Individuals who do not meet the criteria for Moderate or High categories.
Moderate: Meeting one of the following criteria: (1) Three or more days of vigorous activity of at least 20 minutes per day. (2) Five or more days of moderate-intensity activity or walking of at least 30 minutes per day. (3) Five or more days of any combination of walking, moderate-intensity, or vigorous-intensity activities achieving a minimum of at least 600 MET-minutes per week.
High: Meeting one of the following criteria: (1) Vigorous-intensity activity on at least 3 days accumulating at least 1500 MET-minutes per week. (2) Seven or more days of any combination of walking, moderate-intensity, or vigorous-intensity activities accumulating a minimum of at least 3000 MET-minutes per week.
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Physical activity
Unit: Steps and time (hours) Measured with: ActivPAL accelerometers
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Handgrip strength
Unit: Kilograms Measured with: Jamar plus dynamometer
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Isometric Knee Extension Strength
Unit: Kilograms Measured with: Tindeq Progressor 200 dynamometer
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Physical self-concept
Unit: points Measured with: Physical self-concept questionnaire (CAF)
It consists of 36 items, grouped into 6 dimensions. The items are rated on a 5-point Likert-type scale, where 1 means false and 5 means true. The minimum and maximum scores per dimension are 6 and 30, respectively.
Measured: Visit 1 (Baseline), Visit 3 (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start21 Jul 2025
- Primary completion3 Jul 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Catolica de Temuco
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Principal investigator, Dr. Fabián Ignacio Lanuza Rilling, Universidad Catolica de Temuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911346
- Sponsor's protocol ID
- Universidad Catolica de Temuco
- Other IDs
- FONDECYT Iniciación 11250095
- Acronym
- PREDIET-ARAC
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared due to confidentiality agreements with participants. Aggregate data will be included in scientific publications.
Publications
Lanuza F, Romero-Lopez C, Nova-Luna R, Cuyul-Vasquez I, Saez-Venegas M, Guzman N, Diaz-Velis L, Zamora-Ros R, Martinez-Huelamo M, Andres-Lacueva C. Effect of plant-based foods and (poly)phenol supplementation on gut-microbiota metabolism in participants with overweight or obesity and cardiometabolic risk: a study protocol for a single-blind, parallel and randomised controlled trial. BMJ Open. 2025 Sep 16;15(9):e105461. doi: 10.1136/bmjopen-2025-105461.
PubMed 40962336
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Native Plant-Based Foods and (Poly)Phenol Supplementation in Modifying Gut-Microbiota Metabolism: A Strategy for Reducing Body Weight and Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT06911346
- Acronym / sponsor ID
- PREDIET-ARAC / Universidad Catolica de Temuco
- Conditions
- Obesity and Overweight
- Keywords
- Plant-Based Diet, Polyphenol Supplementation, Cardiometabolic Risk, Weight Loss, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Catolica de TemucoUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 4 Apr 2025 (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.
This single-blind, randomized controlled trial aims to evaluate the effects of increased dietary polyphenol intake-either through a healthy plant-based diet (PBD) or supplementation-on body weight and cardiometabolic risk factors in adults with overweight or obesity.
A total of 99 participants (aged 25-45 years, BMI 25-35 kg/m²) with cardiovascular risk factors will be recruited from local health centers and randomly assigned (1:1:1) to one of three intervention groups for 12 weeks: (1) a healthy PBD rich in polyphenols, with supplemental apple, blueberries, hazelnuts, extra-virgin olive oil, and coffee provided at no cost to the participant (2) a healthy diet plus polyphenol supplementation (≈30g/day) from maqui , green tea, olive leaf, cranberry, and grape extracts, or (3) a control group receiving placebo and standard healthy diet recommendations. All groups will follow a caloric deficit.
Dietary intake will be assessed using three 24-hour dietary recalls at baseline and 12 weeks, with polyphenol intake estimated via the Phenol-Explorer database. Data collection will include lifestyle questionnaires, anthropometric and bioimpedance measurements, blood pressure assessments, physical activity monitoring via accelerometers, and strength evaluations. Blood samples will be analyzed using a large-scale targeted metabolomics approach (UHPLC-MS/MS) to identify metabolic signatures, particularly those linked to gut microbiota. Faecal samples will be collected at baseline and visit 3.
Findings will provide insights into how dietary polyphenols-either from whole foods or supplementation-affect obesity-related outcomes and cardiometabolic risk, potentially unveiling gut microbial biomarkers as future therapeutic targets. This study aims to contribute to strategies for obesity and cardiometabolic risk prevention and treatment.
Detailed description
The primary objective of this study is to evaluate the impact of increased dietary polyphenol intake-either through a healthy plant-based diet (PBD) or supplementation-on body weight and cardiometabolic risk factors in adults with overweight or obesity. Additionally, the study seeks to explore the role of gut-microbiota-derived metabolites as potential mediators of these effects through metabolomic analyses.
The calculation determined a required sample size of 90 participants. To account for potential dropouts, a 10% buffer was added, resulting in a final target of 99 participants (33 per group); trial power of 0.8 and alfa error of 5%. A total of 99 participants (aged 25-45 years, BMI 25-35 kg/m²) with at least three cardiometabolic risk factors will be recruited from Health Centers supported by the Health Department of the Municipality in Temuco, Chile.
Participants will be randomly assigned (stratified by sex and age: <35y and ≥35y) in a 1:1:1 ratio to one of three groups for a 12-week intervention, with assessments conducted at baseline, week 6, and week 12:(1) a group following a healthy PBD rich in polyphenols, (2) a group following a healthy diet plus polyphenol supplementation (≈30g/day from maqui, green tea, cranberry, olive leaf and grape extracts), and (3) a control group receiving placebo and standard dietary recommendations. All groups will follow a caloric deficit (~1,200 kcal/day) for the entire 12-week study. This will be explained to each participant during the first visit.
Dietary data will be collected using three 24-hour dietary recalls at baseline and after 12 weeks, employing the SER 24 HDR software. The SER-24H software (University of Chile; Santiago, Chile) developed by CIAPEC (Center for Research in Food Environments and Prevention of Nutrition-Associated Diseases) at INTA, University of Chile, was used for dietary assessment. The Phenol-Explorer database estimates dietary polyphenol intake. It is the first comprehensive database on polyphenol content in foods. It contains more than 35,000 content values for 500 different polyphenols in over 400 foods.
Lifestyle, general health, and physical activity will be assessed through validated questionnaires. Anthropometric and body composition measurements will be taken using bioimpedance analysis. Blood pressure will be monitored with sphygmomanometers, while muscle strength will be measured via dynamometry.
Biological samples, including blood and plasma, will be collected at baseline and after 12 weeks. On each visit, 20ml of blood will be extracted from the antecubital vein and will be centrifuged and stored at -80ºC in the ultra-freezers of the School of Medicine at the Catholic University of Temuco until used.
Additionally, participants will be invited to provide a faecal sample during the first and third visits. These samples are not part of the main study but will be stored at -80ºC for potential future microbiota analyses (School of Medicine at the Catholic University of Temuco).
Biochemical analyses will be performed by institutional laboratory. Blood tests will include rutinary hematology and biochemistry, and inflammatory parameters.
Targeted metabolomic analyses will be conducted using ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UHPLC-MS/MS) to identify and quantify polyphenol-derived metabolites, gut microbial metabolites, and other biochemical markers relevant to obesity and cardiometabolic risk.
Participants in the PBD group will receive a structured dietary plan featuring regional and national polyphenol-rich foods such as blueberries, hazelnuts, olive oil, apples, and coffee. The polyphenol supplementation group will receive a standardized supplement taken twice daily. The control group will receive placebo and standard nutritional counseling.
The study will adhere to ethical guidelines, including the Declaration of Helsinki and Good Clinical Practice principles. Ethical approval will be obtained, and all participants will provide informed consent. Data privacy will be ensured in compliance with applicable regulations.
Statistical analyses will be conducted on an intention-to-treat and per-protocol basis. Primary outcomes include changes in body weight and body composition, while secondary outcomes focus on cardiometabolic risk factors, dietary adherence, and metabolic signatures identified through metabolomics. Differences between pre- and post-intervention data, as well as between groups, will be analyzed using multivariate models, machine-learning algorithms, and generalized linear mixed models (GLMMs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplementation Group | Experimental | Dietary Supplement: Diet supplementationHealthy plant-based diet (plus supplemental foods) as part of a hypocaloric diet. |
| Polyphenol-rich Supplement Group | Experimental | Dietary Supplement: Polyphenol-rich supplementHypocaloric diet with polyphenol-rich supplement. |
| Placebo Control Group | Placebo comparator | Other: PlaceboHypocaloric diet plus Placebo. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age between 25 and 45 years (adult)
- Sexes: All
- Overweight or obesity class I (BMI 25-35 kg/m²)
- At least three of the following cardiometabolic risk factors:
- Current smoker (more than 1 cigarette per day during the last month) Sitting time greater than 7 hours per day or classified as inactive according to the IPAQ Fasting glucose ≥100 mg/dL (5.6 mmol/L)
Key exclusion criteria (7 listed)
- Presence of cardiovascular disease, diabetes, or hypertension
- Severe medical conditions that may impair participation in a nutrition intervention study (e.g., digestive disease, advanced malignancy, major neurological or psychiatric disease)
- Any medical condition limiting survival to less than one year
- Illegal drug use, chronic alcoholism, or problematic alcohol use
- BMI ≥35 kg/m²
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 |
|---|---|---|
| Diet supplementationHealthy plant-based diet (plus supplemental foods) as part of a hypocaloric diet. | Dietary supplement | Dietary Supplementation Group |
| Polyphenol-rich supplementHypocaloric diet with polyphenol-rich supplement. Polyphenol-rich sachets containing ≈30g/day of a combination of plant extracts rich in polyphenol. Frequency: 2 sachets a day. Duration: 12 weeks | Dietary supplement | Polyphenol-rich Supplement Group |
| PlaceboHypocaloric diet plus Placebo. The placebo is a sachet (≈30g/day) with similar appearance, taste, and texture but without active polyphenols. Frequency: 2 sachets a day. Duration: 12 weeks | Other | Placebo Control Group |
Primary outcome
Body weight
Time frame: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Unit: Kilograms Measured with: bioimpedance scan
29 secondary outcomes
Systolic blood pressure
Time frame: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Diastolic blood pressure
Time frame: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Glucose
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Glycosylated hemoglobin
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Insulin
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Triglycerides
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
HDL (high-density lipoprotein)-cholesterol
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
LDL (low-density lipoprotein)-cholesterol
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Total cholesterol
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Waist circumference
Time frame: Visit 1 (baseline), visit 2 (week 6), visit 3 (week 12)
Hip circumference
Time frame: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Fat mass
Time frame: Visit 1 (baseline), visit 2 (week 6), visit 3 (week 12)
Muscle mass
Time frame: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)
Alanine aminotransferase
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Aspartate aminotransferase
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Bilirrubin
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Creatinin
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Urea
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Uric acid
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Hemoglobin
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Erithrocytes
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Leucocytes
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Thyroid-stimulating hormone (TSH)
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Dietary intake
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Physical activity level
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Physical activity
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Handgrip strength
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Isometric Knee Extension Strength
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
Physical self-concept
Time frame: Visit 1 (Baseline), Visit 3 (Week 12)
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 31 Aug 2026.
- Derived from this study: PubMed 40962336Lanuza F, Romero-Lopez C, Nova-Luna R, Cuyul-Vasquez I, Saez-Venegas M, Guzman N, Diaz-Velis L, Zamora-Ros R, Martinez-Huelamo M, Andres-Lacueva C. Effect of plant-based foods and (poly)phenol supplementation on gut-microbiota metabolism in participants with overweight or obesity and cardiometabolic risk: a study protocol for a single-blind, parallel and randomised controlled trial. BMJ Open. 2025 Sep 16;15(9):e105461. doi: 10.1136/bmjopen-2025-105461.
- Individual participant dataSharing planned: No. No individual participant data will be shared due to confidentiality agreements with participants. Aggregate data will be included in scientific publications.
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Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet supplementation and Polyphenol-rich supplement in people with Obesity and Overweight, run by Universidad Catolica de Temuco at 1 site in Chile.
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 11 inclusion and 7 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 31 Aug 2026. 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 Chile. 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?
Body weight (time frame: Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)). 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 NCT06911346, which also lists 1 linked publication.
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 31 Aug 2026.