Peripheral Arterial DiseaseNCT00487617
Arteriopathy and Endothelial Function
A study of Peripheral Arterial Disease, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Arterial Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2007to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peripheral arteriopathy
- Stable cardio-respiratory status
Who cannot join
- Dialysis
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Service de Chirurgie Vasculaire
Strasbourg, 67091
Fabien Thaveau, MD, 33.3.88.11.60.68, fabien.thaveau@chru-strasbourg.fr
Fabien Thaveau, MD
- Recruiting
Service de Physiologie et d'Explorations Fonctionnelles
Strasbourg, 67091
Olivier Rouyer, MD, 33.3.88.11.61.22, olivier.rouyer@chru-strasbourg.fr
Olivier Rouyer, MD
About this study
Official title: Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease
To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value
- Conditions
- Peripheral Arterial Disease
- Being tested
- Fruit juice or placebo absorption
- Keywords
- Arteriopathy, endothelial function, fruit juice
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit juice or placebo absorptionProcedure or surgery
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.
| Study group | Role | What they receive |
|---|---|---|
| fruit juice | Experimental | 300 mL of fruit juice Receives: Procedure: Fruit juice or placebo absorption |
| placebo | Placebo comparator | 300 mL of fruit juice without polyphenols Receives: Procedure: Fruit juice or placebo absorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function 1 hour after taking the juice
Measured: 1 hour after taking the juice
Secondary outcomes (1)
Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Olivier Rouyer, MD, Study director, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487617
- Sponsor's protocol ID
- 3801
- Status last verified
- Feb 2009
- First submitted
- 15 Jun 2007
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00487617
- Acronym / sponsor ID
- 3801
- Conditions
- Peripheral Arterial Disease
- Keywords
- Arteriopathy, endothelial function, fruit juice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fruit juice | Experimental | Procedure: Fruit juice or placebo absorption300 mL of fruit juice |
| placebo | Placebo comparator | Procedure: Fruit juice or placebo absorption300 mL of fruit juice without polyphenols |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Peripheral arteriopathy
- Stable cardio-respiratory status
Key exclusion criteria (1 listed)
- Dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit juice or placebo absorptionabsorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo. | Procedure or surgery | fruit juice, placebo |
Primary outcome
Endothelial function 1 hour after taking the juice
Time frame: 1 hour after taking the juice
1 secondary outcome
Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Rouyer, MD study director
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Peripheral Arterial Disease, run by University Hospital, Strasbourg, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Rouyer, MD (33.3.88.11.61.22, olivier.rouyer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function 1 hour after taking the juice (time frame: 1 hour after taking the juice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2009; AzTrials last refreshed its copy on 1 Nov 2026.