Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 11, 2025
Date Accepted: Apr 15, 2025
Effect of Mediterranean diet adapted to the Mexican population on indicators of metabolic risk in patients with obstructive sleep apnea. Randomized Controlled Trial.
ABSTRACT
Background:
Obstructive sleep apnea (OSA) is characterized by episodes of intermittent airway obstruction during deep sleep or REM. It is associated to cardiometabolic risk diseases. The base treatment is continuous positive airway pressure (CPAP), to which not all patients adapt. The Mediterranean diet has proven to be effective in reducing cardiovascular risk markers; however, it must be adapted to different populations. Among OSA patients, it can effectively reduce clinical entity and cardiometabolic risk, while improving quality of life and sleep.
Objective:
To evaluate the effect of a Mediterranean diet adapted to Mexican diet versus a standard nutritional treatment on metabolic risk indicators in patients with obstructive sleep apnea.
Methods:
A randomized, two-arm clinical trial will be conducted with OSA patients from the Hospital, Mexican Social Security Institute (Instituto Mexicano del Seguro Social, IMSS) in Mexico. Patients will be randomly included in the group assigned Mediterranean diet adapted to Mexican foods or in that given a standard diet for OSA. Fasting blood samples will be drawn after 6 and 12 months to identify glucose levels and lipid profiles. Anthropometric and body composition measurements will be taken, and adherence to diet will be recorded after 3, 6, and 12 months. Sleep quality, physical exercise, and life quality will be recorded basally and after 12 months.
Results:
The protocol was authorized in 2024, and funding is sought for patient follow-up, including patients and RCT, in 2025. Recruiting will start in March 2025, and data analysis and results are expected to be completed by February 2026.
Conclusions:
The results of the present RCT will contribute to evaluate the effect of a nutritional intervention adapted to OSA patients, seeking to reduce cardiovascular risk indicators in patients, improve their clinical condition, reduce OSA symptoms, and improve patients’ quality of life. Clinical Trial: NCT06782737; https://clinicaltrials.gov/study/NCT06278571
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