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Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea

NCT ID: NCT01977924

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Obstructive Sleep Apnea

Keywords

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sleep apnea polyphenols endothelial function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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polyphenols

600 mg polyphenols (grape extract)

Group Type EXPERIMENTAL

one month polyphenols supplementation (600mg)

Intervention Type DIETARY_SUPPLEMENT

Placebo

microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

placebo (microcrystalline cellulose)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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one month polyphenols supplementation (600mg)

Intervention Type DIETARY_SUPPLEMENT

placebo (microcrystalline cellulose)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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wojciech trzepizur, MD

Role: CONTACT

Phone: +33(0) 214353695

Email: [email protected]

References

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Trzepizur W, Bironneau V, Recoquillon S, Priou P, Meslier N, Hamel JF, Henni S, Darsonval A, Messaoudi K, Martinez MC, Andriantsitohaina R, Gagnadoux F. Polyphenols Have No Impact on Endothelial Function in Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial. J Nutr. 2018 Apr 1;148(4):581-586. doi: 10.1093/jn/nxy005.

Reference Type DERIVED
PMID: 29659956 (View on PubMed)

Other Identifiers

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2013-A00763-42

Identifier Type: -

Identifier Source: org_study_id