Effect of a Lipidic and Proteic Controlled Diet on Resting Energy Expenditure, Body Composition and Symptoms in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in resting energy expenditure
研究概览
简要总结
Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in patients with Parkinson's disease.
详细描述
Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in Parkinson's disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of Parkinson's disease, treated with L-Dopa or other dopaminergic drugs.
- •Mini Mental State Examination (MMSE) >
- •Activities of Daily Living >3.
排除标准
- •Mini nutritional assessment <17; BMI <18, hypoalbuminemia or lymphopenia.
- •acute or chronic liver diseases;
- •renal function impairment (Clearance creatinine <30ml/min);
- •acute inflammatory diseases;
- •thyroid diseases;
- •diabetes mellitus;
- •dysphagia;
- •dementia;
- •dyslipidemia;
- •history of recent cardiovascular or cerebrovascular events;
- •psychiatric diseases;
- •iatrogen parkinsonism.
结局指标
主要结局
Changes in resting energy expenditure
时间窗: Baseline, week 4 and week 8
Changes in resting energy expenditure as measured by indirect calorimetry
次要结局
未报告次要终点