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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: different diets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PD patients- Diet B first<br>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. | Dietary Supplement: different diets<br>* 3 different diets: A\B\C<br>|
| Active Comparator: PD patients- Diet C first<br>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. | Dietary Supplement: different diets<br>* 3 different diets: A\B\C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | CGI, PDQ-39 | 4 months | 
| dyskinesias | AIMS | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluctuations | questioners regarding off time | 4 months | 
| motor function | UPDRS | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinson, duodopa, diet, proteins, amino acids