Study of the Impact of the Regular Consumption of Polyphe... | NCT02028936

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 24, 2013Actual

Primary Completion Date

Jun 17, 2014Actual

Completion Date

Jun 17, 2014Actual

First Submitted Date

Dec 18, 2013

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2019

Last Update Posted Date

Jan 10, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Label	Type	Description	Intervention Names
Grape juice rich in polyphenols	Experimental		Other: Grape juice R@isol
grape juice not enriched with polyphenols	Active Comparator		Other: Commercially-available grape juice

Name	Type	Description	Arm Group Labels	Other Names
Grape juice R@isol	Other		Grape juice rich in polyphenols
Commercially-available grape juice

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

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided