NCT00487617

Brief Summary

To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

June 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 25, 2009

Status Verified

February 1, 2009

Enrollment Period

4.3 years

First QC Date

June 15, 2007

Last Update Submit

February 24, 2009

Conditions

Peripheral Arterial Disease

Keywords

Arteriopathyendothelial functionfruit juice

Outcome Measures

Primary Outcomes (1)

  • Endothelial function 1 hour after taking the juice

    1 hour after taking the juice

Secondary Outcomes (1)

  • Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years

    3 years

Study Arms (2)

fruit juice

EXPERIMENTAL

300 mL of fruit juice

Procedure: Fruit juice or placebo absorption

placebo

PLACEBO COMPARATOR

300 mL of fruit juice without polyphenols

Procedure: Fruit juice or placebo absorption

Interventions

Fruit juice or placebo absorptionPROCEDURE

absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.

fruit juiceplacebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peripheral arteriopathy
  • Stable cardio-respiratory status

You may not qualify if:

  • Dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Chirurgie Vasculaire

Strasbourg, 67091, France

RECRUITING

Service de Physiologie et d'Explorations Fonctionnelles

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Fruit and Vegetable Juices

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Olivier Rouyer, MD

    Hôpitaux Universitaires de Strasbourg

    STUDY DIRECTOR

Central Study Contacts

Olivier Rouyer, MD

CONTACT

33.3.88.11.61.22olivier.rouyer@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2007

First Posted

June 18, 2007

Study Start

July 1, 2007

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

February 25, 2009

Record last verified: 2009-02

Locations

FR(2)