Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.

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.

Inclusion Criteria:

• Comunnity-dwelling persons.
• Any ethnicity.
• With willingness to consume the bar daily during the intervention period.

Exclusion Criteria:

• Allergy/intolerance to ingredients in the bar.
• Pregnancy or breastfeeding.
• Use of antioxidant/polymeroid supplements in the last 4 weeks.
• Unstable chronic diseases (e.g., severe liver failure, advanced kidney failure, active cancer).
• Persons in treatments that strongly interfere with polyphenol metabolism (e.g., antibiotics, anti-inflammatories, corticosteroids, anti-allergy medication).
• Persons with metal prosthesis.
• Persons undergoing or waiting for metabolic bariatric surgery.
• Persons with scheduled digestive surgery within the next 8 weeks
• Persons in recent treatments for hypertension (less than 3 month).
• Participation in another clinical trial.