Polyphenols and Endothelial Function

This study has suspended participant recruitment.

Sponsor:

Information provided by:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT00619749

First received: February 7, 2008

Last updated: August 18, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2008

Last Updated Date

August 18, 2011

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Flow-mediated dilatation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00619749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Exercise, capacity memory [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Polyphenols and Endothelial Function

Official Title ^ICMJE

Polyphenols Rich Fruit Juice Effects on Endothelial Function and Exercise Capacity

Brief Summary

To determine whether fruit juice rich in polyphenols might increase exercise capacity and memory in healthy sedentary subjects.Both parameters might be improved because of the anti-oxidant effects of polyphenols.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Sedentary Subjects

Intervention ^ICMJE

Dietary Supplement: juice rich in polyphenols
juice during 2 weeks
Dietary Supplement: juice poor in polyphenols
juice during 2 weeks

Study Arm (s)

Experimental: 1
Intervention: Dietary Supplement: juice rich in polyphenols
Placebo Comparator: 2
Intervention: Dietary Supplement: juice poor in polyphenols

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2012

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

sedentary

Exclusion Criteria:

diabetes

Gender

Both

Ages

30 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00619749

Other Study ID Numbers ^ICMJE

4125

Has Data Monitoring Committee

Responsible Party

Emmanuel Lavoué, directeur adjoint de la recherche clinique et de l'innovation, Hôpitaux Universitaires de Strasbourg

Study Sponsor ^ICMJE

University Hospital, Strasbourg, France

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bernard geny, MD

Hôpitaux Universitaires de Strasbourg

Information Provided By

University Hospital, Strasbourg, France

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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