Mediterranean-type Diet for Older Adults With Obstructive Sleep Apnea: Randomized Clinical Trial - MedOOSA Project
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
The majority of the elderly present with sleep apnea and mortality is significantly higher in this group. Sleep apnea runs the risk of developing diseases, especially hypertension and cardiovascular disease, while the Mediterranean diet is associated with reduced risk.
No study evaluated the effect of the Mediterranean diet on the apnea and hypopnea index in the elderly. Therefore, the present work intends to evaluate the effect of the intervention with the Mediterranean diet on the apnea-hypopnea index in the elderly with moderate sleep apnea.
The hypothesis study is that the elderly with moderately severe sleep apnea under a Mediterranean-type diet will modify AHI in the short term, regardless of weight change, due to changes in body volume and ingestion, especially those related to body water.
详细描述
PRIMARY OBJECTIVE:
To evaluate the effect of the Mediterranean diet intervention on the apnea-hypopnea index in the elderly with moderate-severe sleep apnea.
SECONDARY OBJECTIVES:
- To compare the effect of intervention with Mediterranean diet on the effect of low-fat diet (control) on anthropometric variables (BMI, neck and waist circumferences) and bioimpedance (body water, lean mass, fat mass).
- To compare the effect of the intervention with a diet of the Mediterranean type to the effect of the intervention with a low-fat diet (control) on glycolipid profile, C-reactive protein, Sodium, and Potassium.
- To compare the effect of the Mediterranean diet intervention on the effect of the low-fat diet (control) on blood pressure: systolic, diastolic and heart rate measured in 24-hour ABPM.
PROCEDURES:
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
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreement to sign the ICF;
- •AHI between 15 and 50 events/h;
- •Age between 65 and 80 years;
- •Both sexes;
- •BMI between 27-39.9 kg / m2.
排除标准
- •In treatment for sleep apnea;
- •Predominantly central sleep apnea;
- •Feed predominantly of meals provided by third parties;
- •Gastrointestinal disease, with intolerance to fat intake;
- •Impossibility to follow the Mediterranean diet due to the presence of mastication and/or swallowing disorders;
- •History of food allergy with hypersensitivity to any of the components of olive oil and/or oleaginous;
- •Eating habits in the last two months that characterize the diet of the Mediterranean;
- •Significant alterations in appetite in the last three months or change of weight over 5 kg in the last three months;
- •Illegal use of drugs or chronic alcoholism, clinically significant depression or ongoing psychiatric care;
- •Inability to communicate;
- •Severe chronic diseases;
- •Self-reported terminal disease;
- •Plan to move city in two months;
- •Participation in another clinical trial.
结局指标
主要结局
Apnea-hypopnea index
时间窗: 12 weeks
Evaluated with portable polygraphy.
次要结局
- Body weight(12 weeks)
- Body composition(12 weeks)
- Cholesterol total(12 weeks)
- LDL-Cholesterol(12 weeks)
- Triglycerides(12 weeks)
- glucose(12 weeks)
- HDL-cholesterol(12 weeks)