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

NCT02028936 | Completed

• 1 other identifier: BARDOU FUI 2013
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Measurement of plasma levels of hydroxyoctadecadienoic acid

  At inclusion, 15 days and 3 months.

Secondary Outcomes (1)

• Measurement of endothelial function

  At the inclusion and 3 month

Study Arms (2)

Grape juice rich in polyphenols

EXPERIMENTAL

Other: Grape juice R@isol

grape juice not enriched with polyphenols

ACTIVE COMPARATOR

Other: Commercially-available grape juice

Interventions

Grape juice R@isol OTHER

Grape juice rich in polyphenols

Commercially-available grape juice OTHER

grape juice not enriched with polyphenols

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 present a history of or current use of psycho-active substances (drugs such as cocain, morphine, heroin...).
• Persons with diabetes treated with insulin or oral antidiabetics.
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Name CHU Dijon

Dijon, 21079, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 7, 2014
• Study Start: October 24, 2013
• Primary Completion: June 17, 2014
• Study Completion: June 17, 2014
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

FR (1)