An interventional study of Fortifit® and Control Group in Disability Physical, sponsored by Emanuele Cereda. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Emanuele Cereda · Not applicable, Interventional, and Treatment
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
235 studies on the registry are indexed under Parkinsonian Disorders; 69 are open to participants now.
This study's enrollment of 150 is above the median of 55 across 143 interventional studies indexed under Parkinsonian Disorders.
Browse Parkinsonian Disorders studies →Emanuele Cereda is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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®
Best local diet
Other: Control Group
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.
Best local diet
Functional status - distance walked during the six minutes walking test
Change in the distance walked during the six minutes walking test
Time frame: 30 days
Functional status - timed up and go test
Change in timed up and go test
Time frame: 30 days
Functional status - Berg balance scale
Change in Berg balance scale score
Time frame: 30 days
Functional status - handgrip strength
Change in handgrip strength
Time frame: 30 days
Functional status - gait speed
Change in gait speed (4 minutes walking test)
Time frame: 30 days
Self-perceived functional status
Change in Self-assessment Parkinson's Disease Disability Scale
Time frame: 30 days
Body weight
Change in body weight
Time frame: 30 days
Muscle mass
Change in muscle mass
Time frame: 30 days
Adverse events
Occurrence of adverse events
Time frame: 30 days
Treatment continuation
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Time frame: 30 days
Plan to share: Undecided
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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