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NCT Number: NCT06782737

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietetic interventión with mediterranean diet

Other

Personalized dietary Mediterranean diet

Other names: Mediterranean diet

Primary outcomes

  1. glucose

    Time frame: 12 months

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

  2. tryglicerides

    Time frame: 12 months

    Blood triglyceride level at baseline and end of study

  3. body mass index

    Time frame: 12 months

    body mass index

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

Effect of the Mediterranean Type Diet Versus Standard Diet on Cardiometabolic Indicator in Patients With Obstructive Sleep Apnea

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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