Parkinson Disease
Conditions
Keywords
parkinson, duodopa, diet, proteins, amino acids
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).
Interventions
3 different diets: A\\B\\C
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 4 months | CGI, PDQ-39 |
| dyskinesias | 4 months | AIMS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fluctuations | 4 months | questioners regarding off time |
| motor function | 4 months | UPDRS |