Plant-Based Foods and (Poly)Phenol Supplementation in Gut Microbiota Modulation, Body Weight, and Cardiometabolic Risk

NCT06911346 | Active Not Recruiting DMC

• 2 other identifiers: Universidad Catolica de TemucoFONDECYT Iniciación 11250095
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity and Overweight

Keywords

Plant-Based Diet; Polyphenol Supplementation; Cardiometabolic Risk; Weight Loss; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• Body weight

  Unit: Kilograms Measured with: bioimpedance scan

  Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)

Secondary Outcomes (29)

• Systolic blood pressure

  Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)

• Diastolic blood pressure

  Visit 1 (Baseline), Visit 2 (Week 6), Visit 3 (Week 12)

• Glucose

  Visit 1 (Baseline), Visit 3 (Week 12)

• Glycosylated hemoglobin

  Visit 1 (Baseline), Visit 3 (Week 12)

• Insulin

  Visit 1 (Baseline), Visit 3 (Week 12)

Study Arms (3)

Dietary Supplementation Group

EXPERIMENTAL

Healthy plant-based diet (plus supplemental foods) as part of a hypocaloric diet.

Dietary Supplement: Diet supplementation

Polyphenol-rich Supplement Group

EXPERIMENTAL

Hypocaloric diet with polyphenol-rich supplement.

Dietary Supplement: Polyphenol-rich supplement

Placebo Control Group

PLACEBO COMPARATOR

Hypocaloric diet plus Placebo.

Other: Placebo

Interventions

Diet supplementation DIETARY_SUPPLEMENT

Healthy plant-based diet (plus supplemental foods) as part of a hypocaloric diet.

Dietary Supplementation Group

Polyphenol-rich supplement DIETARY_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

Polyphenol-rich Supplement Group

Placebo OTHER

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

Placebo Control Group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Catolica de Temuco: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Fabian Lanuza

Temuco, Región de la Araucanía, 4780000, Chile

Location

Related Publications (1)

• 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.

  PMID: 40962336 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In addition to participant masking, investigators and outcome assessors will remain blinded to group assignments. Only the principal investigator will have access to the allocation information, while the rest of the research team will identify participants by ID only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)