Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters. (RESINCA)
May 18, 2026 updated by: Center for Research and Innovation Viña Concha y Toro
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ileana González Bonet, Dr
- Phone Number: +56 71 2986000
- Email: ileanag@ucm.cl
Study Contact Backup
- Name: Andrea Herrera Santelices, Dr
- Phone Number: +56 71 2986000
- Email: aherreras@ucm.cl
Study Locations
-
-
Maule Region
-
Talca, Maule Region, Chile
- Universidad Católica del Maule
-
Contact:
- Dr. Ileana González Bonet
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: RES 120
This is the control group
|
This grape pomace bar have 120 mg of total polyphenols contents
Other Names:
|
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Experimental: RES 250
This is the experimental group 1
|
This grape pomace bar is enriched with resveratrol until reach 250 mg of total polyphenols contents
Other Names:
|
|
Experimental: RES 500
This is the experimental group 2
|
This grape pomace bar is enriched with resveratrol until reach 500 mg of total polyphenols contents
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The total plasma antioxidant capacity by Ferric Reducing Antioxidant Power will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Inflammatory Biomarkers: Ultra-sensitivity CRP (mg/L).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The ultra-sensitivity CRP by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Inflammatory Biomarkers: IL-6 (pg/mL).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The IL-6 by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Inflammatory Biomarkers: Plasma malondialdehyde (µmol/L).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The plasma malondialdehyde by TBARS/HPLC method will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Inflammatory Biomarkers: TNF-alfa (pg/mL).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The TNF-alfa by Elisa test will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Inflammatory Biomarkers: Advanced glycation end-products (AGEs) in 1 to 5 units.
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The AGEs will assess with non-invasive fluorescence pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiometabolic Parameters: Body weight (kg).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Body weight will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic Parameters: Body mass index-BMI (kg/m2).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The BMI will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic Parameters: Basal metabolic rate (kcal).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The basal metabolic rate will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic Parameters: Fat mass (kg, %).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The fat mass will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic Parameters: Skeletal muscle mass (kg).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The skeletal muscle mass will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic Parameters: Waist-to-hip ratio.
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The waist-to-hip ratio will assess with electrical bioimpedance pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic Parameters: Handgrip strength (kg).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The handgrip strength will assess with dynamometry pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic Parameters: 30-second sit-to-stand test (n° of repetitions achieved).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The 30-second sit-to-stand test will assess with a 43 cm height chair pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: HRV, RMSSD and SDNN in (ms).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The heart rate variability will assess in 10 minutes with continuous recording of the resting electrocardiographic tracing pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: PNN50 (%).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The heart rate variability will assess in 10 minutes with continuous recording of the resting electrocardiographic tracing pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: Insuline (µIU/mL).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The fasting insulin by immunoassay will assess by a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: Glucose (mg/dL).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The fasting glucose by enzymatic method will assess by a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: HOMA-IR (index).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The HOMA-IR (calculated by fasting glucose x fasting insulin/405) will assess by a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: Lipid profile (mg/dL).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The lipid profile: total cholesterol, LDL, HDL and Triglycerides by enzymatic method will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: Liver profile (U/L).
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The liver profile: ALS, AST, GGT: by enzymatic method will assess with a blood sample pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
|
Cardiometabolic parameters: Blood pressure (mmHg)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
The systolic and diastolic blood pressure will assess with a sphygmomanometer pre and post intervention to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on cardiometabolic parameters in community-dwelling adults.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Gerard Casaubon Cruzat, Center for Research and Innovation Viña Concha y Toro
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pastor RF, Restani P, Di Lorenzo C, Orgiu F, Teissedre PL, Stockley C, Ruf JC, Quini CI, Garcia Tejedor N, Gargantini R, Aruani C, Prieto S, Murgo M, Videla R, Penissi A, Iermoli RH. Resveratrol, human health and winemaking perspectives. Crit Rev Food Sci Nutr. 2019;59(8):1237-1255. doi: 10.1080/10408398.2017.1400517. Epub 2017 Dec 5.
- Chiva-Blanch G, Badimon L. Effects of Polyphenol Intake on Metabolic Syndrome: Current Evidences from Human Trials. Oxid Med Cell Longev. 2017;2017:5812401. doi: 10.1155/2017/5812401. Epub 2017 Aug 15.
- Breuss JM, Atanasov AG, Uhrin P. Resveratrol and Its Effects on the Vascular System. Int J Mol Sci. 2019 Mar 27;20(7):1523. doi: 10.3390/ijms20071523.
- Huang H, Chen G, Liao D, Zhu Y, Pu R, Xue X. The effects of resveratrol intervention on risk markers of cardiovascular health in overweight and obese subjects: a pooled analysis of randomized controlled trials. Obes Rev. 2016 Dec;17(12):1329-1340. doi: 10.1111/obr.12458. Epub 2016 Jul 26.
- Springer M, Moco S. Resveratrol and Its Human Metabolites-Effects on Metabolic Health and Obesity. Nutrients. 2019 Jan 11;11(1):143. doi: 10.3390/nu11010143.
- Chudzinska M, Rogowicz D, Wolowiec L, Banach J, Sielski S, Bujak R, Sinkiewicz A, Grzesk G. Resveratrol and cardiovascular system-the unfulfilled hopes. Ir J Med Sci. 2021 Aug;190(3):981-986. doi: 10.1007/s11845-020-02441-x. Epub 2020 Nov 21.
- Hou CY, Tain YL, Yu HR, Huang LT. The Effects of Resveratrol in the Treatment of Metabolic Syndrome. Int J Mol Sci. 2019 Jan 28;20(3):535. doi: 10.3390/ijms20030535.
- Mousavi SM, Milajerdi A, Sheikhi A, Kord-Varkaneh H, Feinle-Bisset C, Larijani B, Esmaillzadeh A. Resveratrol supplementation significantly influences obesity measures: a systematic review and dose-response meta-analysis of randomized controlled trials. Obes Rev. 2019 Mar;20(3):487-498. doi: 10.1111/obr.12775. Epub 2018 Dec 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
January 16, 2026
First Submitted That Met QC Criteria
January 31, 2026
First Posted (Actual)
February 9, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECA Resveratrol - FIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
In order to protect the privacy, data will be stored and coded.
At the end of the study, data may be available upon a reasonable request and ensuring the participants' data confidentiality will be preserved.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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