JMIR research protocols · 2025
Effect of a Mediterranean Diet Adapted to the Mexican Population on Indicators of Metabolic Risk in Patients With Obstructive Sleep Apnea: Protocol for a Randomized Controlled Trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Torres San Miguel Gittaim Pammela, Sevilla González María de la Luz, López Ramírez Eduardo, Flores López María Fernanda, Velázquez López Lubia
Аннотация
BACKGROUND: Obstructive sleep apnea (OSA) is characterized by episodes of intermittent airway obstruction during deep sleep or REM (rapid eye movement). It is associated with cardiometabolic risk diseases. The base treatment is continuous positive airway pressure (CPAP), to which not all patients are able to adapt. The Mediterranean diet (MD) has proven to be effective in reducing cardiovascular risk markers; however, it must be adapted to different populations. Among patients with OSA, it can effectively reduce clinical entity and cardiometabolic risk, while improving quality of life and sleep.
OBJECTIVE: We aimed to evaluate the effect of an MD adapted to the Mexican diet versus a standard nutritional treatment on metabolic risk indicators in patients with OSA.
METHODS: A randomized, 2-arm clinical trial will be conducted with patients with OSA from the Hospital, Mexican Social Security Institute (Instituto Mexicano del Seguro Social) in Mexico. Patients will be randomly included in the group with MD adapted to Mexican foods. With a personalized diet plan adapted from the Mediterranean diet, prototype menus with Mexican foods adapted from the MD will be included for a higher consumption of fruit, vegetables, fiber-rich cereals, and reduction of red meat. In addition to an illustrative plate to improve adherence. The standard diet (SD) group will receive standardized nutritional counseling for patients with 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. A multivariate logistic regression analysis will be performed, including the achievement of metabolic indicator control goals, sleep quality, and quality of life as outcome variables. This analysis will be adjusted for other variables that may be statistically significant in the bivariate analysis, such as sex, age, and comorbidities, among others. Statistically significant differences between groups will be considered when the value of P<.05.
RESULTS: The protocol was authorized in 2024, and funding is being sought for patient follow-up. All 120 patients (60 per group) will be included in 2025; recruitment will begin in March 2025. The clinical trial is expected to be completed in April 2026.
CONCLUSIONS: The results of this study will contribute to evaluate the effect of a nutritional intervention adapted to patients with OSA, seeking to reduce cardiovascular risk indicators in patients, improve their clinical condition, reduce OSA symptoms, and improve patients' quality of life.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06278571; https://clinicaltrials.gov/study/NCT06278571.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/72513.
OBJECTIVE: We aimed to evaluate the effect of an MD adapted to the Mexican diet versus a standard nutritional treatment on metabolic risk indicators in patients with OSA.
METHODS: A randomized, 2-arm clinical trial will be conducted with patients with OSA from the Hospital, Mexican Social Security Institute (Instituto Mexicano del Seguro Social) in Mexico. Patients will be randomly included in the group with MD adapted to Mexican foods. With a personalized diet plan adapted from the Mediterranean diet, prototype menus with Mexican foods adapted from the MD will be included for a higher consumption of fruit, vegetables, fiber-rich cereals, and reduction of red meat. In addition to an illustrative plate to improve adherence. The standard diet (SD) group will receive standardized nutritional counseling for patients with 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. A multivariate logistic regression analysis will be performed, including the achievement of metabolic indicator control goals, sleep quality, and quality of life as outcome variables. This analysis will be adjusted for other variables that may be statistically significant in the bivariate analysis, such as sex, age, and comorbidities, among others. Statistically significant differences between groups will be considered when the value of P<.05.
RESULTS: The protocol was authorized in 2024, and funding is being sought for patient follow-up. All 120 patients (60 per group) will be included in 2025; recruitment will begin in March 2025. The clinical trial is expected to be completed in April 2026.
CONCLUSIONS: The results of this study will contribute to evaluate the effect of a nutritional intervention adapted to patients with OSA, seeking to reduce cardiovascular risk indicators in patients, improve their clinical condition, reduce OSA symptoms, and improve patients' quality of life.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06278571; https://clinicaltrials.gov/study/NCT06278571.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/72513.