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

January 16, 2025 updated by: Lubia Velázquez López, Coordinación de Investigación en Salud, Mexico

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Once the inclusion criteria have been confirmed, a detailed explanation of the study will be given, and the responsible investigators will clarify any doubts about the study. The patient will freely agree to participate in the research by signing the informed consent letter.

The following measurements will be taken in all patients:

Sociodemographic and clinical data. A medical interrogation will be made by the research team to collect sociodemographic data, pathological and non-pathological clinical history. The patient will be questioned about his or her age, clinical history with pathological and non-pathological personal history, pharmacological and non-pharmacological treatment.

Blood Pressure Measurement Blood pressure will be measured by the medical team participating in the study, with a calibrated sphygmomanometer, without previous coffee consumption, without having smoked or consumed cola in the last 30 minutes. The patient will be seated in a chair, with his back supported, without crossing his feet.

. Measurement of sleep variables. In the first time consultation of the Sleep Clinic, parameters of AHI and ODI will be taken with the CPAP equipment, which is part of the studies that are routinely performed in patients with obstructive sleep apnea. It lasts 7 to 8 hours.

Polysomnography: We will proceed to the assembly of the channels that make up the polysomnography: electroencephalographic and electro-oculogram derivations, electromyogram of chin and legs, respiratory flow signals thermistor and/or nasal cannula, respiratory effort signals, continuous oxygen monitoring, electrocardiogram, and determination of the patient's body position.

Measurement of biochemical indicators. With the patient fasting for 8 to 10 hours, a blood sample will be taken in venous blood to measure glucose, lipid profile (Cholesterol, Triglycerides, LDH, VLDL). Measurements to be taken at the first consultation, 6 and 12 months.

Anthropometric and body composition measurements The measurement of the anthropometric data will be done by the nutritionists participating in this research, previously standardized.for the measurement of the body composition the InBody equipment will be used, where the percentage of fat, fat mass, lean mass, total liquids will be obtained.

The Epworth Sleepiness Scale, sleep diary, as well as measures and applied sleep changes will be used. The Epworth Sleepiness Scale (ESE) assesses 8 items, each with a 0 to 3 point response, where 0 means no likelihood of nodding off or falling asleep, 1 means slight likelihood of nodding off or falling asleep, 2 moderate likelihood of nodding off or falling asleep, and 3 high likelihood of falling asleep. If the patient scores 1 to 6 it is considered normal sleep, 7 to 8 points average sleepiness, and 9 to 24 points pathological (abnormal) sleepiness.

Apnea-hypopnea index.

This will be obtained through CPAP readings where the level of severity of OSA before and after the intervention will be calculated. It will be classified:

  • Mild: apnea-hypopnea index ≥ 5 and < 15 per hour.
  • Moderate: apnea-hypopnea index ≥ 15 and ≤ 30 per hour.
  • Severe: apnea-hypopnea index > 30 per hour. Measurement of quality of life It will be obtained from the QSQ questionnaire (Quebec Sleep Questionnaire) which has been validated in Hispanic population.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Cdmx
      • Ciudad de mexico, Cdmx, Mexico, 03100
        • Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Mediterranean diet

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
Personalized dietary Mediterranean diet
Other Names:
  • Mediterranean diet
No Intervention: Control

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose
Time Frame: 12 months
blood glucose level at baseline and at the end of the study
12 months
tryglicerides
Time Frame: 12 months
Blood triglyceride level at baseline and end of study
12 months
body mass index
Time Frame: 12 months
body mass index
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of sleep quality
Time Frame: The baseline and 12 months after the intervention will be evaluated.

Measurement of sleep quality The Epworth Sleepiness Scale, sleep diary, as well as measures and applied sleep changes will be used. The Epworth Sleepiness Scale (ESE) assesses 8 items, each with a 0 to 3 point response, where 0 means no likelihood of nodding off or falling asleep, 1 means slight likelihood of nodding off or falling asleep, 2 moderate likelihood of nodding off or falling asleep, and 3 means high probability of falling asleep. If the patient obtains a score of 1 to 6 is considered normal sleep, 7 to 8 points average sleepiness, and 9 to 24 points pathological sleepiness (anaesthesia).

pathological (abnormal) sleepiness. Apnea-hypopnea index.
The baseline and 12 months after the intervention will be evaluated.
Measurement of quality of life
Time Frame: The baseline and 12 months after the intervention will be evaluated.

It will be obtained from the QSQ questionnaire (Quebec Sleep Questionnaire) which has been validated in the Hispanic population.

in the Hispanic population. It consists of 32 items focused on measuring daily sleepiness: items 7, 16, 20, 27, 31, 32,

Daytime symptoms: 1, 10, 11, 14, 17, 17, 18, 19, 23, 26, 29. Nighttime symptoms:

4, 9, 21, 22, 25, 28, 30. Emotions: 5, 6, 8, 15, 24. Social interactions: 2, 3, 12, 13.

This questionnaire will be applied at baseline and 12 months follow-up.
The baseline and 12 months after the intervention will be evaluated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Investigators

  • Principal Investigator: Lubia Velazquez, PhD, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Actual)

December 13, 2024

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2024-3609-055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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