Mediterranean Diet Versus Standard Diet on Candiormetabolic Indicator in Patients With Apnea

NCT06782737 | Enrolling By Invitation DMC

• 1 other identifier: R-2024-3609-055
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; obesity; cardiometabolic risk; mediterranean diet; nutritional therapy

Outcome Measures

Primary Outcomes (3)

• glucose

  blood glucose level at baseline and at the end of the study

  12 months

• tryglicerides

  Blood triglyceride level at baseline and end of study

  12 months

• body mass index

  body mass index

  12 months

Secondary Outcomes (2)

• Measurement of sleep quality

  The baseline and 12 months after the intervention will be evaluated.

• Measurement of quality of life

  The baseline and 12 months after the intervention will be evaluated.

Study Arms (2)

Intervention Mediterranean diet

EXPERIMENTAL

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.

Other: Dietetic interventión with mediterranean diet

Control

NO INTERVENTION

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.

Interventions

Dietetic interventión with mediterranean diet OTHER

Personalized dietary Mediterranean diet

Also known as: Mediterranean diet

Intervention Mediterranean diet

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Anatomical alterations of the nose, oropharynx or maxilla.
• Chronic kidney disease in substantive treatment of renal function
• Decompensated heart failure
• Cancer
• Depression
• Anxiety
• Neurological disease.
• Treatment with benzodiazepines, antidepressants, anxiolytics and hypnotics.
• Refractory Dyslipidemia
• Familial Dyslipidemia
• Surgeries in less than 6 months

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Instituto Mexicano Del Seguro Social

Mexico City, Mexico City, 03100, Mexico

Location

Related Publications (8)

• Carneiro-Barrera A, Amaro-Gahete FJ, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Buela-Casal G, Ruiz JR. Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e228212. doi: 10.1001/jamanetworkopen.2022.8212.

  PMID: 35452108 BACKGROUND

• Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.

  PMID: 25940230 BACKGROUND

• Godos J, Ferri R, Lanza G, Caraci F, Vistorte AOR, Yelamos Torres V, Grosso G, Castellano S. Mediterranean Diet and Sleep Features: A Systematic Review of Current Evidence. Nutrients. 2024 Jan 17;16(2):282. doi: 10.3390/nu16020282.

  PMID: 38257175 BACKGROUND

• Liu Y, Wheaton AG, Chapman DP, Cunningham TJ, Lu H, Croft JB. Prevalence of Healthy Sleep Duration among Adults--United States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Feb 19;65(6):137-41. doi: 10.15585/mmwr.mm6506a1.

  PMID: 26890214 RESULT

• Powell TA, Mysliwiec V, Brock MS, Morris MJ. OSA and cardiorespiratory fitness: a review. J Clin Sleep Med. 2022 Jan 1;18(1):279-288. doi: 10.5664/jcsm.9628.

  PMID: 34437054 RESULT

• Gaines J, Vgontzas AN, Fernandez-Mendoza J, Bixler EO. Obstructive sleep apnea and the metabolic syndrome: The road to clinically-meaningful phenotyping, improved prognosis, and personalized treatment. Sleep Med Rev. 2018 Dec;42:211-219. doi: 10.1016/j.smrv.2018.08.009. Epub 2018 Sep 3.

  PMID: 30279095 RESULT

• Valenza MC, Martin Martin L, Gonzalez Jimenez E, Aguilar Cordero MJ, Botella Lopez M, Munoz Casaubon T, Valenza Demet G. [Risk factors for metabolic syndrome in a population with sleep apnea; evaluation in a population of Granada; the Granada study]. Nutr Hosp. 2012 Jul-Aug;27(4):1255-60. doi: 10.3305/nh.2012.27.4.5825. Spanish.

  PMID: 23165570 RESULT

• Salman LA, Shulman R, Cohen JB. Obstructive Sleep Apnea, Hypertension, and Cardiovascular Risk: Epidemiology, Pathophysiology, and Management. Curr Cardiol Rep. 2020 Jan 18;22(2):6. doi: 10.1007/s11886-020-1257-y.

  PMID: 31955254 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lubia Velazquez, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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 OSA patients. The Mifflin-St. Mifflin equation will be applied to determine the energy needs of each patient. To achieve energy requirements and distribution. Patients in this group will receive individual nutritional counseling at the beginning of the study on hygienic sleep measures and Mediterranean-type diet adjusted to foods in Mexico that are accessible and inexpensive. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Investigator

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 20, 2025
• Study Start: October 15, 2024
• Primary Completion: December 13, 2024
• Study Completion: February 15, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)