Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea (PolySAS)

November 12, 2013 updated by: University Hospital, Angers

Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea: a Randomized Controlled Trial

Severe obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity and mortality. Endothelial dysfunction, an early marker of vascular disease has been demonstrated in OSA. Regular treatment of OSA by continuous positive airway pressure (CPAP) improves endothelial function and is associated with a reduction in cardiovascular risk. Approximately 40% of patients with OSA are intolerant or insufficiently adherent to CPAP. Alternative treatments or adjuvants to the CPAP are needed.

The polyphenols have demonstrated their effectiveness in improving endothelial function in patients with CV disease. No randomized controlled studies have evaluated the impact of PPR on the endothelial dysfunction associated with OSAHS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The endpoint is the change to one month of polyphenols treatment of the endothelial function measured by the index of hyperemic reactivity.

The secondary endpoints are changes at one month of supplementation with polyphenols of ambulatory blood pressure measurement in 24 hours (MAPA), micro-circulatory responsiveness, the speed of the pulse wave and biological measurements (lipid profile, blood glucose, fasting insulin, leptin, adiponectin, hs-CRP, 8-isoprostane levels and cellular origin of microparticles).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:•

  • apnea hypopnea index > 30
  • accepting polyphenols supplementation
  • Signed informed consent

Exclusion Criteria:

  • Epworth sleepiness scale > 16/24
  • Severe cardiac and/or respiratory disease
  • BMI>35 kg/m2
  • Anemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: polyphenols
600 mg polyphenols (grape extract)
Dietary supplement: one month polyphenols supplementation (600mg)
Placebo Comparator: Placebo
microcrystalline cellulose
Dietary supplement: placebo (microcrystalline cellulose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endothelial function measured by the index of hyperemic reactivity
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00763-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on one month polyphenols supplementation (600mg)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe