Tests a Mediterranean-style diet in adults with obstructive sleep apnea
Compares a Mediterranean-style diet with standard diet in people with sleep apnea.
Plain-language title generated from the registry record
Registry title: Mediterranean Diet Versus Standard Diet on Candiormetabolic Indicator in Patients With Apnea
Key facts
- Where
- Mexico City, MexicoSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 70 years old?
Source: NCT06782737, who can take part
Where in Mexico
- Instituto Mexicano del Seguro SocialMexico City, MexicoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Coordinación de Investigación en Salud, Mexico
- Trial code
- NCT06782737
- Record updated
- 20 January 2025
- Original description
Introduction. Worldwide, obstructive sleep apnea is estimated to affect one in seven individuals. Patients with OSA present chronic low-grade inflammation related to arteriosclerosis. The effect of the Mediterranean diet on metabolic risk indicators is still inconclusive in the OSA population.Read full original descriptionShow less
Effect of the Mediterranean Type Diet Versus Standard Diet on Cardiometabolic Indicator in Patients With Obstructive Sleep Apnea
Introduction. Worldwide, obstructive sleep apnea is estimated to affect one in seven individuals. Patients with OSA present chronic low-grade inflammation related to arteriosclerosis. The effect of the Mediterranean diet on metabolic risk indicators is still inconclusive in the OSA population.
Objective: To evaluate the effect of a Mediterranean diet adapted to the Mexican diet, versus standard nutritional treatment, on metabolic risk indicators in patients with obstructive sleep apnea.
Material and methods: Randomized clinical trial in patients with OSA confirmed by polysomnography. Sociodemographic data, pathological and non-pathological history, as well as clinical data will be collected by interview. Patients will be randomly assigned to the group with personalized Mediterranean-type diet adapted to the Mexican diet or standard diet for patients with OSA. At baseline, 6 and 12 months with the patient fasting, glucose levels and lipid profile in venous blood will be measured, as well as carotid artery thickness. Anthropometry and body composition measurements will also be taken, in addition to questionnaires to measure sleep quality, physical exercise and quality of life, as well as to measure dietary adherence with 3-day food records. A descriptive analysis of qualitative variables will be performed with frequencies and percentages; quantitative variables will be presented according to their free or parametric distribution. An X2 will be performed to compare the difference between the proportions of the outcome variables, as well as a Student's t-test or Mann Whitney U test according to their parametric or free distribution. A multivariate analysis will be performed to see the effect of both interventions on the main outcome variables, obesity, dyslipidemia and glycemic control.
Inclusion: Men and women; Clinical diagnosis of sleep apnea; Diagnosis of moderate and severe OSA.
Exclusion: Treatment with benzodiazepines, antidepressants, anxiolytics and hypnotics; Chronic kidney disease in substantive treatment of renal function; Decompensated heart failure; Cancer; Neurological disease; Anatomical alterations of the nose, oropharynx or maxilla; Depression; Anxiety; Refractory Dyslipidemia; Familial Dyslipidemia; Surgeries in less than 6 months.