Polyphenols and Endothelial Function

This study is currently recruiting participants.

Verified by University Hospital, Strasbourg, France, March 2008

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00619749

Purpose

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.

Condition	Intervention	Phase
Sedentary Subjects	Dietary Supplement: juice rich in polyphenols Dietary Supplement: juice poor in polyphenols	Phase III

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Polyphenols Rich Fruit Juice Effects on Endothelial Function and Exercise Capacity

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2010
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Dietary Supplement: juice rich in polyphenols juice during 2 weeks
2: Placebo Comparator	Dietary Supplement: juice poor in polyphenols juice during 2 weeks

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

sedentary

Exclusion Criteria:

diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619749

Contacts

Contact: Bernard Geny, MD

0033388 11 61 22

Bernard.Geny@physio-ulp.u-strasbg.fr

Locations

France
Service de Physiologie et Explorations Fonctionnelles Hôpitaux Universitaires	Recruiting
Strasbourg, France
Contact: Bernard Geny, MD 00333 88 11 61 22 Bernard.Geny@physio-ulp.u-strasbg.fr
Sub-Investigator: Olivier Rouyer, MD
Sub-Investigator: Samy Talha, MD
Sub-Investigator: Paola Di Marco, MD
Sub-Investigator: Stéphane Doutreleau, MD
Sub-Investigator: Anne Charloux, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Bernard geny, MD

Hôpitaux Universitaires de Strasbourg

More Information

Responsible Party:	Hôpitaux Universitaires de Strasbourg ( Emmanuel Lavoué, directeur adjoint de la recherche clinique et de l'innovation )
Study ID Numbers:	4125
Study First Received:	February 7, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00619749
Health Authority:	France: Afssaps - French Health Products Safety Agency

ClinicalTrials.gov processed this record on January 16, 2009