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Effects of Resveratrol Supplementation on Inflammatory Biomarkers and Cardiometabolic Parameters in Community-dwelling Adults. (RESINCA-trial)
This study aims to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers and cardiometabolic parameters in community-dwelling adults
Three groups will be studied: control group (RES 120), experimental group 1 (RES 250) and experimental group 2 (RES 500). During 8 weeks the RES 120 group will received daily one grape pomace bars with 120 mg of total polyphenols contents (TPC), the RES 250 group will received daily one grape pomace bars enriched with resveratrol until reach 250 mg of TPC and the RES 500 group will received daily one grape pomace bars enriched with resveratrol until reach 500 mg of TPC. Outcomes will be assessed at baseline and after 8 weeks. At the end of the study, the groups that shows less o no effects will be invited to enjoy the bar showing to be more effective. Primary outcomes are: Total plasma antioxidant capacity (TAC), ultra-sensitivity CRP, IL-6, TNF-alfa, plasma malondialdehyde and AGEs. Secondary outcomes are: body weight, Body Mass Index (BMI), basal metabolic rate, fat mass, skeletal muscle mass, and waist-to-hip ratio. Handgrip strength, 30-second sit-to-stand test, and heart rate variability. Fasting insulin, fasting glucose, HOMA-IR. Lipid profile, liver profile, blood pressure. All procedures will be performed at the clinical simulation center of the Faculty of Medicine of the Catholic University of Maule. The sample size was estimated under the following criteria, using G\*Power software (version 3.1): Primary outcome: Total Plasma Antioxidant Capacity (TAC). Type of comparison: differences between parallel groups. Level of significance (α): 0.05 (bilateral). Stat (1 - β): 80%. Minimum expected difference (Δ): 0.25 TAC units. Standard deviation (σ): 0.30 TAC units. Balanced allocation between groups (1:1:1). The minimum sample size required is 23 participants per group, considering an estimated loss or dropout rate of 15-20%, the sample size was increased to 27- 30 participants per group.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Universidad Católica del Maule
Talca, Maule Region, Chile
Start Date
April 1, 2026
Primary Completion Date
August 31, 2026
Completion Date
September 30, 2026
Last Updated
February 9, 2026
75
ESTIMATED participants
RES 120
DIETARY_SUPPLEMENT
RES 250
DIETARY_SUPPLEMENT
RES 500
DIETARY_SUPPLEMENT
Lead Sponsor
Center for Research and Innovation Viña Concha y Toro
Collaborators
NCT06817252
NCT06942351
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06983145