AzTrials
AzTrials

Inflammation BiomarkersRESINCANCT07395921

Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.

A study testing RES 120, RES 250 and RES 500 in people with Inflammation Biomarkers and Cardiometabolic Health Indicators, run by Center for Research and Innovation Viña Concha y Toro at 1 site in Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
RES 120, RES 250 and RES 500
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteChile
Study dates
1 Jun 2026to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ileana González Bonet, Dr contact

+56 71 2986000

ileanag@ucm.cl

Andrea Herrera Santelices, Dr contact

+56 71 2986000

aherreras@ucm.cl

Chile1 site
  • Universidad Católica del Maule

    Talca, Maule Region

    Dr. Ileana González Bonet

Other trials in Chile

About this study

Official title: 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

Read the 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.

Being tested
RES 120, RES 250, RES 500
Keywords
Resveratrol, inflammation, inflammaging, antioxidant, cardiometabolic health, nutritional intervention
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RES 120Dietary supplement

    Also called Nuvaoxi

    This grape pomace bar have 120 mg of total polyphenols contents

  • RES 250Dietary supplement

    Also called Nuvaoxi 250

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

  • RES 500Dietary supplement

    Also called Nuvaoxi 500

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

Study groups in NCT07395921
Study groupRoleWhat they receive
RES 120Sham comparatorThis is the control group
Receives: Dietary Supplement: RES 120
RES 250ExperimentalThis is the experimental group 1
Receives: Dietary Supplement: RES 250
RES 500ExperimentalThis is the experimental group 2
Receives: Dietary Supplement: RES 500

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  2. Inflammatory Biomarkers: Ultra-sensitivity CRP (mg/L).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Inflammatory Biomarkers: IL-6 (pg/mL).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  4. Inflammatory Biomarkers: Plasma malondialdehyde (µmol/L).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  5. Inflammatory Biomarkers: TNF-alfa (pg/mL).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  6. Inflammatory Biomarkers: Advanced glycation end-products (AGEs) in 1 to 5 units.

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (16)
  1. Cardiometabolic Parameters: Body weight (kg).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  2. Cardiometabolic Parameters: Body mass index-BMI (kg/m2).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  3. Cardiometabolic Parameters: Basal metabolic rate (kcal).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  4. Cardiometabolic Parameters: Fat mass (kg, %).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  5. Cardiometabolic Parameters: Skeletal muscle mass (kg).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  6. Cardiometabolic Parameters: Waist-to-hip ratio.

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  7. Cardiometabolic Parameters: Handgrip strength (kg).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  8. Cardiometabolic Parameters: 30-second sit-to-stand test (n° of repetitions achieved).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  9. Cardiometabolic parameters: HRV, RMSSD and SDNN in (ms).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  10. Cardiometabolic parameters: PNN50 (%).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  11. Cardiometabolic parameters: Insuline (µIU/mL).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  12. Cardiometabolic parameters: Glucose (mg/dL).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  13. Cardiometabolic parameters: HOMA-IR (index).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  14. Cardiometabolic parameters: Lipid profile (mg/dL).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  15. Cardiometabolic parameters: Liver profile (U/L).

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

  16. Cardiometabolic parameters: Blood pressure (mmHg)

    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.

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This Clinical Trial will be carried out with 3 parallel arms.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395921
Sponsor's protocol ID
ECA Resveratrol - FIC
Acronym
RESINCA
Status last verified
May 2026
First submitted
16 Jan 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 28894509
  • 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.

    PubMed 30934670
  • 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.

    PubMed 27456934
  • 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.

    PubMed 30641865
  • 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.

    PubMed 29206058
  • 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.

    PubMed 33219913
  • 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.

    PubMed 30695995
  • 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.

    PubMed 30515938

Questions about this trial

What is this clinical trial studying?

A study testing RES 120, RES 250 and RES 500 in people with Inflammation Biomarkers and Cardiometabolic Health Indicators, run by Center for Research and Innovation Viña Concha y Toro at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ileana González Bonet, Dr (+56 71 2986000, ileanag@ucm.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory biomarkers: Total plasma antioxidant capacity (µmol/L). (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07395921, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in