Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07395921

Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Inflammation Biomarkers Antioxidant Capabilities Antioxidant Status, Inflammation Cardiometabolic Health Indicators Inflammaging Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica del Maule

Talca, Maule Region, Chile

Location contact

Dr. Ileana González Bonet

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RES 120

Dietary Supplement

This grape pomace bar have 120 mg of total polyphenols contents

Other names: Nuvaoxi

RES 250

Dietary Supplement

This grape pomace bar is enriched with resveratrol until reach 250 mg of total polyphenols contents

Other names: Nuvaoxi 250

RES 500

Dietary Supplement

This grape pomace bar is enriched with resveratrol until reach 500 mg of total polyphenols contents

Other names: Nuvaoxi 500

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Herrera Santelices, Dr

CONTACT

[email protected]

+56 71 2986000

Ileana González Bonet, Dr

CONTACT

[email protected]

+56 71 2986000

Sponsors and collaborators

Lead sponsor

Center for Research and Innovation Viña Concha y Toro

Industry

Collaborators

  • Universidad Católica del Maule

Registry information

Official study title

Effects of Resveratrol Supplementation on Inflammatory Biomarkers and Cardiometabolic Parameters in Community-dwelling Adults. (RESINCA-trial)

Acronym: RESINCA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.