Effect of the Mediterranean Type Diet Versus Standard Diet on Cardiometabolic Indicator in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Clinical diagnosis of sleep apnea
- •Diagnosis of moderate and severe OSA
排除标准
- •Anatomical alterations of the nose, oropharynx or maxilla.
- •Chronic kidney disease in substantive treatment of renal function
- •Decompensated heart failure
- •Depression
- •Neurological disease.
- •Treatment with benzodiazepines, antidepressants, anxiolytics and hypnotics.
- •Refractory Dyslipidemia
- •Familial Dyslipidemia
- •Surgeries in less than 6 months
研究组 & 干预措施
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.
干预措施: Dietetic interventión with mediterranean diet (Other)
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.
结局指标
主要结局
glucose
时间窗: 12 months
blood glucose level at baseline and at the end of the study
tryglicerides
时间窗: 12 months
Blood triglyceride level at baseline and end of study
body mass index
时间窗: 12 months
body mass index
次要结局
- 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.)
研究者
Lubia Velázquez López
Titular Investigator
Coordinación de Investigación en Salud, Mexico