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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月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
dyskinesias

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

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

结局指标

主要结局

dyskinesias

时间窗: 4 months

AIMS

quality of life

时间窗: 4 months

CGI, PDQ-39

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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