NCT00619749

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

3.9 years

First QC Date

February 7, 2008

Last Update Submit

July 7, 2016

Conditions

Sedentary Subjects

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilatation

    2 years

Secondary Outcomes (1)

  • Exercise, capacity memory

    2 years

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: juice rich in polyphenols

2

PLACEBO COMPARATOR
Dietary Supplement: juice poor in polyphenols

Interventions

juice rich in polyphenolsDIETARY_SUPPLEMENT

juice during 2 weeks

1
juice poor in polyphenolsDIETARY_SUPPLEMENT

juice during 2 weeks

2

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • sedentary

You may not qualify if:

  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Physiologie et Explorations Fonctionnelles Hôpitaux Universitaires

Strasbourg, France

Location

MeSH Terms

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Bernard geny, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 21, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

FR(1)