NCT03124277
Completed
Not Applicable
A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Patients With Parkinsonism Undergoing Rehabilitation Treatment: a Randomized Trial
Emanuele Cereda1 site in 1 country150 target enrollmentApril 26, 2017
ConditionsDisability Physical
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Disability Physical
- Sponsor
- Emanuele Cereda
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Functional status - distance walked during the six minutes walking test
- Status
- Completed
- Last Updated
- last year
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
Investigators
Emanuele Cereda
Co-Project Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
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
Outcomes
Primary Outcomes
Functional status - distance walked during the six minutes walking test
Time Frame: 30 days
Change in the distance walked during the six minutes walking test
Secondary Outcomes
- Adverse events(30 days)
- Functional status - timed up and go test(30 days)
- Self-perceived functional status(30 days)
- Functional status - Berg balance scale(30 days)
- Functional status - gait speed(30 days)
- Muscle mass(30 days)
- Treatment continuation(30 days)
- Functional status - handgrip strength(30 days)
- Body weight(30 days)
Study Sites (1)
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