NCT02274324

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	different diets	3 different diets: A\\B\\C

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2014-10-24
• Last updated: 2014-10-24