Nutritional Support for Rehabilitation In Parkinsonism

Study Overview
=================
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

Official Title
-----------------
A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Patients With Parkinsonism Undergoing Rehabilitation Treatment: a Randomized Trial

Conditions
-----------------
Disability Physical

Intervention / Treatment
-----------------
* Dietary Supplement: Fortifit®
* Other: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortifit®<br>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. | Dietary Supplement: Fortifit®<br>* 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.<br>|
| Other: Control group<br>Best local diet | Other: Control Group<br>* Best local diet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |