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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02274324
• Other study ID #: 1310-14-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: October 22, 2014
• Last updated: October 23, 2014
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2014
• Source: Sheba Medical Center
• Contact: Esther Stein, B.Sc
• Phone: +972-3-5304931
• Email: Esther.Stein[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Dietary Supplement:
• different diets
3 different diets: A\B\C

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Tel Aviv University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	CGI, PDQ-39	4 months	No
Primary	dyskinesias	AIMS	4 months	No
Secondary	fluctuations	questioners regarding "off" time	4 months	No
Secondary	motor function	UPDRS	4 months	No