Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- quality of life
研究概览
简要总结
To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in patients with PD treated with Duodopa®. This is in search for an optimal diet that will accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and thus improve motor function and quality of life.
详细描述
A prospective single-blind-crossover study in patients with PD regularly treated with Duodopa® (LICG) in which three different diets will be given. Diet A: Low fat western diet - traditional low-fat Western diet; a normal diet according to the recommendations of health organizations in which proteins consumed throughout the day, high-protein meal at noon and in the evening.
Diet B: Equal protein redistribution diet (EPRD) - proteins consumption is controlled and equally distributed over six meals throughout the day to minimize motor fluctuations.
Diet C: Protein redistribution diet (PRD) in which proteins are consumed in the morning prior to connection to the pump and in the evening after disconnecting from the . Carbohydrates and fats will be consumed during the day.
Following recruitment and study initiation patients will consume diet A for 3 weeks. Patients will then be randomized into either diet B or diet C for 3 additional weeks. At completion of this period patients will consume diet A for 2 weeks ("wash-out" period) and will then be "crosseovered" to get the third diet (B or C).
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with Duodopa at least three months and are stable on medical therapy
- •Patients should be not demented, able to fill diaries and to sign an informed consent
排除标准
- •Severe dementia
- •Inability to fill out diaries
- •Unstable mediated condition
- •Chronic renal failure
研究组 & 干预措施
PD patients- Diet B first
Patients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet B and then crossover to diet C.
干预措施: different diets (Dietary Supplement)
PD patients- Diet C first
Patients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet C and then crossover to diet B.
干预措施: different diets (Dietary Supplement)
结局指标
主要结局
quality of life
时间窗: 4 months
CGI, PDQ-39
dyskinesias
时间窗: 4 months
AIMS
次要结局
- fluctuations(4 months)
- motor function(4 months)
研究者
Dr. Oren Cohen
Dr
Sheba Medical Center
