Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects (Fijus Raisol)

January 9, 2019 updated by: Centre Hospitalier Universitaire Dijon

Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects: a Prospective Randomised Double-blind Study

Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.

Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress.

The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

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 Locations

  • France
      • Dijon, France, 21079
        • Name CHU Dijon

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects aged from 18 to 50 years
  • Men and women
  • With national health insurance cover
  • With a Body Mass Index between 18.5 and 27.9
  • Who have given their written informed consent to take part in the study.

Exclusion Criteria:

  • Subjects unable to understand the nature and aims of the study and/or those who have difficulty communicating with the investigator.
  • Adults under ward of court.
  • Those in custody following a decision of the court or the administration.
  • Subjects with a risk of a major change in their diet during the trial.
  • Those who drink more than 5 cups of tea or coffee a day.
  • Those who consumed more than 25 grammes of alcohol a day, every day of the year preceding the inclusion visit.
  • Those who present a history of or current use of psycho-active substances (drugs such as cocain, morphine, heroin...).
  • Subjects currently in a period of exclusion relative to another research protocol or for whom the annual cummulation of payments for participation in biomedical research has reached the annual ceiling.
  • Presence of any treated chronic disease, and any acute disease within the 4 weeks preceding the inclusion and randomisation visit.
  • Persons with diabetes treated with insulin or oral antidiabetics.
  • Subjects on lipid-lowering therapy and/or on antioxidants (such as vitamin E, vitamin C, selenium, ß-carotene, Zinc) in the month preceding inclusion.
  • Subjects taking multivitamin supplements in the month preceding inclusion.
  • Pregnant or breast-feeding women

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grape juice rich in polyphenols
Other: Grape juice R@isol
Active Comparator: grape juice not enriched with polyphenols
Other: Commercially-available grape juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of plasma levels of hydroxyoctadecadienoic acid
Time Frame: At inclusion, 15 days and 3 months.
At inclusion, 15 days and 3 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of endothelial function
Time Frame: At the inclusion and 3 month
At the inclusion and 3 month

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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)

October 24, 2013

Primary Completion (Actual)

June 17, 2014

Study Completion (Actual)

June 17, 2014

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BARDOU FUI 2013

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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