Status:
ACTIVE_NOT_RECRUITING
Plant-Based Foods and (Poly)Phenol Supplementation in Gut Microbiota Modulation, Body Weight, and Cardiometabolic Risk
Lead Sponsor:
Universidad Catolica de Temuco
Collaborating Sponsors:
Agencia Nacional de Investigación y Desarrollo
Conditions:
Obesity and Overweight
Eligibility:
All Genders
25-45 years
Phase:
NA
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...
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 cardiometabol...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 3 2026
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06911346
Start Date
July 21 2025
End Date
June 3 2026
Last Update
November 28 2025
Active Locations (1)
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1
Fabian Lanuza
Temuco, Región de la Araucanía, Chile, 4780000