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| Name | Class |
|---|---|
| ASST Gaetano Pini-CTO | OTHER |
| U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia | UNKNOWN |
| Ospedale Generale Di Zona Moriggia-Pelascini | OTHER |
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This randomized, trial will tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o parkinsonism
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fortifit® | Experimental | Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. |
|
| Control group | Other | Best local diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortifit® | Dietary Supplement | Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status - distance walked during the six minutes walking test | Change in the distance walked during the six minutes walking test | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status - timed up and go test | Change in timed up and go test | 30 days |
| Functional status - Berg balance scale | Change in Berg balance scale score |
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Inclusion Criteria:
Exclusion Criteria:
More than 10 μg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
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| Name | Affiliation | Role |
|---|---|---|
| Michela Barichella, MD | Centro Parkinson, ASST Gaetano Pini-CTO di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Parkinson, ASST Gaetano Pini-CTO | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31278117 | Derived | Barichella M, Cereda E, Pinelli G, Iorio L, Caroli D, Masiero I, Ferri V, Cassani E, Bolliri C, Caronni S, Maggio M, Ortelli P, Ferrazzoli D, Maras A, Riboldazzi G, Frazzitta G, Pezzoli G. Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome. Neurology. 2019 Jul 30;93(5):e485-e496. doi: 10.1212/WNL.0000000000007858. Epub 2019 Jul 5. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control Group | Other | Best local diet |
|
| 30 days |
| Functional status - handgrip strength | Change in handgrip strength | 30 days |
| Functional status - gait speed | Change in gait speed (4 minutes walking test) | 30 days |
| Self-perceived functional status | Change in Self-assessment Parkinson's Disease Disability Scale | 30 days |
| Body weight | Change in body weight | 30 days |
| Muscle mass | Change in muscle mass | 30 days |
| Adverse events | Occurrence of adverse events | 30 days |
| Treatment continuation | Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale | 30 days |
| D008722 | Methods |