Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease

Not Applicable

• Conditions: Parkinson Disease

• Registration Number: NCT02274324
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• Severe dementia
• Inability to fill out diaries
• Unstable mediated condition
• Chronic renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
dyskinesias	4 months	AIMS
quality of life	4 months	CGI, PDQ-39

Secondary Outcome Measures

Name	Time	Method
motor function	4 months	UPDRS
fluctuations	4 months	questioners regarding "off" time