Arteriopathy and Endothelial Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00487617
First received: June 15, 2007
Last updated: February 24, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention
Peripheral Arterial Disease
Procedure: Fruit juice or placebo absorption

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Endothelial function 1 hour after taking the juice [ Time Frame: 1 hour after taking the juice ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fruit juice
300 mL of fruit juice
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.
Placebo Comparator: placebo
300 mL of fruit juice without polyphenols
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peripheral arteriopathy
  • Stable cardio-respiratory status

Exclusion Criteria:

  • Dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487617

Contacts
Contact: Olivier Rouyer, MD 33.3.88.11.61.22 olivier.rouyer@chru-strasbourg.fr

Locations
France
Service de Physiologie et d'Explorations Fonctionnelles Recruiting
Strasbourg, France, 67091
Contact: Olivier Rouyer, MD    33.3.88.11.61.22    olivier.rouyer@chru-strasbourg.fr   
Principal Investigator: Olivier Rouyer, MD         
Sub-Investigator: Bernard Geny, MD         
Service de Chirurgie Vasculaire Recruiting
Strasbourg, France, 67091
Contact: Fabien Thaveau, MD    33.3.88.11.60.68    fabien.thaveau@chru-strasbourg.fr   
Principal Investigator: Fabien Thaveau, MD         
Sub-Investigator: Nabil Chakfe, MD         
Sub-Investigator: Jean-Georges Kretz, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Olivier Rouyer, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00487617     History of Changes
Other Study ID Numbers: 3801
Study First Received: June 15, 2007
Last Updated: February 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Arteriopathy
endothelial function
fruit juice

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 13, 2014