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临床试验/NCT02274324
NCT02274324Unknown不适用

Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease

Sheba Medical Center0 个研究点目标入组 20 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Oren Cohen

Dr

Sheba Medical Center

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