Disability Physical
Conditions
Brief summary
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
Interventions
DIETARY_SUPPLEMENTFortifit®
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.
OTHERControl Group
Best local diet
Sponsors
ASST Gaetano Pini-CTO
U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia
Ospedale Generale Di Zona Moriggia-Pelascini
Emanuele Cereda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Parkinson's disease o parkinsonism * admission for physical rehabilitation * Informed consent
Exclusion criteria
* Any malignant disease during the last five years * Known kidney failure (previous glomerular filtration rate \<30 ml/min); * Known liver failure (Child B or C) * Psychiatric disease * Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis) * Indications related to the study product: 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. * Known allergy to milk, milk products or other components of the proposed interventions * Indication to or ongoing artificial nutrition support * Inclusion in other nutrition intervention trials * Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * Refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional status - distance walked during the six minutes walking test | 30 days | Change in the distance walked during the six minutes walking test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional status - Berg balance scale | 30 days | Change in Berg balance scale score |
| Functional status - handgrip strength | 30 days | Change in handgrip strength |
| Functional status - gait speed | 30 days | Change in gait speed (4 minutes walking test) |
| Self-perceived functional status | 30 days | Change in Self-assessment Parkinson's Disease Disability Scale |
| Functional status - timed up and go test | 30 days | Change in timed up and go test |
| Muscle mass | 30 days | Change in muscle mass |
| Adverse events | 30 days | Occurrence of adverse events |
| Treatment continuation | 30 days | Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale |
| Body weight | 30 days | Change in body weight |
Countries
Italy
Outcome results
None listed