The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial (MEDOSAHS)

February 26, 2014 updated by: Christopher Papandreou, University of Crete
This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnoea-hypopnoea syndrome (OSAHS) is considered to be one of the most prevalent sleep-related breathing disorders, with an enormous effect on public health. Approximately 2-4% of the general adult population experiences some degree of this syndrome. This percentage increases even more with obesity, up to 20-40%, especially in individuals with an excessive body mass index (BMI) > 30 kg/m2. OSAHS is associated with significant systemic consequences, including cardiovascular morbidity and mortality, and the risk increases with the severity of the syndrome. The pathophysiology underlying the link between OSAHS and the cardiovascular system is attributed largely to systemic inflammation and oxidative stress, which are both contributors to endothelial dysfunction. The treatment modalities of OSAHS include continuous positive airway pressure (CPAP), weight loss, upper airway surgery, and medication. CPAP is the first line therapy, as a means of maintaining upper airway patency, and it is well known that this intervention reduces morbidity and mortality. In severe cases of OSAHS the weight loss strategy is essential and must accompany CPAP treatment. A growing body of evidence in OSAHS supports the beneficial role of weight reduction, induced by diet alone or in combination with exercise, leading to a reduction in apnoeas and hypopnoeas.We aim to evaluate the effect of the Mediterranean diet compared with that of a prudent diet on obese OSAHS patients who were treated with CPAP while receiving counselling to increase their physical activity.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Greece
      • Heraklion, Greece, 2208
        • University of Crete

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with apnoea-hypopnoea index >15/h and Epworth Sleepiness Scale > 10

Exclusion Criteria:

  • Diseases such as ischaemic heart disease, diabetes mellitus, thyroid disorders, and malignancies
  • Upper airway surgery
  • Gestation
  • Alcoholism
  • Diet for weight reduction during the last 6 months
  • Eating habits close to the Mediterranean diet at the entry phase
  • Intake of antioxidant supplements
  • Medications affecting weight
  • Smoking (in the case of TBARS)
  • Therapy with sleeping pills
  • Use of anti-depressive medication
  • BMI < 30.0 Kg/m2

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prudent diet group
Participants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity.
Behavioral: Prudent diet group
EXPERIMENTAL: Mediterranean diet group
Participants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity.
Behavioral: Mediterranean diet group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
OSAS severity
The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.

Secondary Outcome Measures

Outcome Measure
AHI during REM sleep and lipid peroxidation marker TBARS

Other Outcome Measures

Outcome Measure
Measure Description
Anthropometric measurements
weight, height, waist circumference and neck circumference

Collaborators and Investigators

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

Sponsor

University of Crete

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, 2008

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (ESTIMATE)

March 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT01312558

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.

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