Enrolling by invitationNo phase

Tests a Mediterranean-style diet in adults with obstructive sleep apnea

Compares a Mediterranean-style diet with standard diet in people with sleep apnea.

Key facts

Who runs it: Coordinación de Investigación en Salud, Mexico
Where: Mexico City, MexicoSee the site
Trial code: NCT06782737
Registry title: Mediterranean Diet Versus Standard Diet on Candiormetabolic Indicator in Patients With Apnea
Status: Enrolling by invitation
People taking part: 120 people, planned
Started: 15 Oct 2024
Planned end: 15 Feb 2026
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: Dietetic interventión with mediterranean diet
Record updated: 20 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate or severe obstructive sleep apnea. It compares a Mediterranean-type diet with a standard diet.

Age: 30 to 70 years
Sex: Men and women can join.
Disease stage: Moderate or severe obstructive sleep apnea, with a clinical diagnosis of sleep apnea.
Earlier treatment: People who take benzodiazepines, antidepressants, anxiolytics or hypnotics cannot join. Surgery in the last 6 months is also an exclusion.

Main reasons for not taking part

Anatomical changes of the nose, oropharynx or maxilla
Chronic kidney disease on treatment of kidney function
Decompensated heart failure
Cancer, depression, anxiety or a neurological disease
Refractory or familial dyslipidemia

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

Men and women
Clinical diagnosis of sleep apnea
Diagnosis of moderate and severe OSA

Who cannot take part

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

Check if you might fit

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?

Where in Mexico

Instituto Mexicano del Seguro SocialMexico City, MexicoNo longer taking part

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

Intervention Mediterranean dietTreatment being tested
Patients in this group will be given a normocaloric diet with the following energy distribution (Protein: 15-20%, Carbohydrate: 50-55%, Fat: 25-30%, Saturated fat: \<7%) according to the guidelines for adult patients with OSA. The Mifflin-St. Mifflin equation will be applied to determine the energy needs of each patient. They will receive individual nutritional counseling at the beginning of the study on hygienic sleep measures and Mediterranean-type diet adjusted to foods in Mexico. Pre-established menus will be calculated with foods that are characteristic of the Mediterranean-type diet, containing fruits, vegetables, whole grains, cereals, white meat content. Sample menus: Weekly menus will be designed to guide the indicated meal plan of the patients. The menus to be designed will be of 1200, 1400, 1600, 1800, 1800, 2000 and 2200 calories. Specifications will be given for the promotion of foods with higher complex carbohydrate content, white meats, fruits and vegetables.
Treatment: Dietetic interventión with mediterranean diet
ControlNo study treatment, for comparison
Patients in this group will be given a normocaloric diet with the following energy distribution (Protein: 15-20%, Carbohydrate: 50-55%, Fat: 25-30%, Saturated fat: \<7%) according to the guidelines for adult patients with OSA. The Mifflin-St. Mifflin equation will be applied to determine the energy needs of each patient. To achieve energy needs and distribution, a specific meal plan containing common foods divided into food equivalent groups will be administered to patients. Nutritional counseling will be considered on an individual basis on hygienic sleep measures and type of diet for weight loss according to age, sex, current body weight and present comorbidity. At the beginning of the intervention, a 24-hour food reminder will be made to know their usual diet. They will be given a triptych for adherence to the indicated diet.