Biological Effects in Consumers of Resveratrol-enriched Wine

August 7, 2023 updated by: PINER Pastor Manfredi Winery

The objective of this clinical trial is to compare the health conditions of the participating population before and after an intervention with Resveratrol enriched wine.

The main questions it aims to answer are:

  1. • The consumption of wine enriched with resveratrol could slow down or reverse the biological age ?
  2. • The consumption of wine enriched with resveratrol could improve body composition fat mass / muscle mass ? The participants will be evaluated at the beginning and at the end of the clinical trial and will adopt only one change in their habits, that is, change the usual wine they consume with their meals for a wine enriched with resveratrol, in a moderate measure, 250 cc for men and 125 cc/day for women. The design of the study will be that each volunteer is their own control, pre and post intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study objectives The objective of the study is to determine the possible relationship between the consumption of pure Malbec wine 100% enriched with pure resveratrol (150 mg/L of wine) ingested during meals, with biomarkers (oxidative stress, DNA damage, antioxidant defenses and chronic systemic inflammation in blood and urine), generated in the body by the damage produced by the oxidative stress of metabolism, age and chronic pathologies.

Procedures to follow

  1. First visit A doctor will take details of your medical history, perform a complete physical examination, and explain the reasons for the study. If you meet the criteria and are eligible to be included in the study, you will only be told not to take dietary supplements or antioxidants and you will be seen again in the office two weeks later. At that time, you will be asked to carry out a blood laboratory analysis. These will be the Baseline Controls.

  2. Visits 30, 60, 90 days:

    Each period between consultations is 30 days, during which time the participant follows a free diet. At the end of each month, you will go for a medical consultation and be given the resveratrol-enriched wine. In the 4th consultation (90 days) the procedure of the first consultation will be repeated. That is, Consultation + Fasting blood extraction.

    Observations of eventual adverse events will be recorded; the information will be recorded in the CRF (Clinical Research Form).

    All the instruments used will be used only for you (disposable material), to avoid all types of contagion or infection.

  3. Biochemical Analysis Determination of analysis to perform on the samples obtained from venous blood, initial and final at 90 days.

    samples. Venous blood will be obtained with heparin at both moments according to the protocol, with a 12-h fast. Start and end at 90 days.

    Determinations. Analysis of oxidative damage, analysis of enzymatic antioxidant defenses, inflammatory response in polymorphonuclear cells (PMN), red blood cells, plasma, and general biochemical analysis will be performed.

    Biochemical-Clinical Studies

    1. Ferritin
    2. Complete blood count w/Platelet count
    3. Mean cell volume
    4. RDW - Red Distribution Width
    5. Ultrasensitive PCR
    6. Glycemia
    7. Creatinine
    8. albumin
    9. Alkaline Phosphatase
  4. Body composition analysis The determination of the InBody analysis will be carried out at the beginning and at the end of the study.

Statistical analysis: The statistical analysis was performed using the Student t-test for paired samples (Prism 7.0, GraphPad, San Diego, CA, USA). The Student t-test was selected to evaluate a single biomarker at a time in eight series of paired data (D0 vs. D90 for chronological and DNAm PhenoAge, muscle mass and fat mass) for each patient before and after the intervention. Results with p < 0.05 were considered significant.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires City
      • Buenos Aires, Buenos Aires City, Argentina, 1408
        • Raul Francisco Pastor

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

Sampling Method

Probability Sample

Study Population

Healthy volunteers and with risk factors of cardiovascular diseases

Description

Inclusion Criteria:

  1. Age 1.1 Minimum 40 years 1.2 Maximum 80 years
  2. Gender 2.1 Male 2.2 Female
  3. Habits 3.1 Regular wine consumers

Exclusion criteria

  1. Age 1.1 under 40 years 1.2 over 80 years
  2. Modifications in treatments during the clinical trial 2.1 Pharmacological 2.2 Non-Pharmacological.
  3. Pregnant women.
  4. Women in planned pregnancy during the study period.
  5. Women in the lactation period.
  6. Patients who have been hospitalized for an infectious disease.
  7. Patients suffering from autoimmune pathologies.
  8. Patients who have cancer.
  9. Patients with gastrointestinal pathologies.
  10. Patients who have a history of liver disease.
  11. Patients who have a history of kidney disease.
  12. Patients who have hematological disease.
  13. Patients who present disorders of the disease of psychiatric origin.
  14. Patients who have epilepsy.
  15. Patients with allergies to the active principles of: 15.1 Wine 15.2 Resveratrol.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenetic age
Time Frame: 3 months
DNAm Phenoage
3 months
InBody muscle mass
Time Frame: 3 months
Body composition
3 months
Body composition
Time Frame: 3 months
InBody fat mass
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PINER Pastor Manfredi Winery

Collaborators

University of Buenos Aires

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

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 (Actual)

July 15, 2022

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #26122021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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