NCT06911346Completed
Plant-Based Foods and (Poly)Phenol Supplementation in Gut Microbiota Modulation, Body Weight, and Cardiometabolic Risk
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 28 Mar 2025
- Start date
- 21 Jul 2025
- Primary completion date
- 3 Jul 2026
- Lead sponsor
- Universidad Catolica de Temuco
- Diseases
- Obesity
- NCT number
- NCT06911346
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 21 Jul 2025 to the primary completion date, 3 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Illegal drug use, chronic alcoholism, or problematic alcohol use
Other illness
- 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
Other
- 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
Who the study is looking for
- 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:
- 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
Age in the registry: 25 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fabian Lanuza Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.