Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tel Aviv University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD patients- Diet B first | Active Comparator | 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. |
|
| PD patients- Diet C first | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| different diets | Dietary Supplement | 3 different diets: A\B\C |
|
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | CGI, PDQ-39 | 4 months |
| dyskinesias | AIMS | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| fluctuations | questioners regarding "off" time | 4 months |
| motor function | UPDRS | 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Stein, B.Sc | Contact | +972-3-5304931 | Esther.Stein@sheba.health.gov.il | |
| Yafit Ben-Mordechai, B.Sc | Contact | +972-54-9919219 | yafit@nutracoach.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Hassin, Dr | Sheba Medical Center | Study Director |
| Oren Cohen, Dr | Sheba Medical Center | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |