Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2017-04-26
2018-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fortifit®
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.
Fortifit®
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
Best local diet
Control Group
Best local diet
Interventions
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Fortifit®
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
Best local diet
Eligibility Criteria
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Inclusion Criteria
* admission for physical rehabilitation
* Informed consent
Exclusion Criteria
* 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
ALL
No
Sponsors
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ASST Gaetano Pini-CTO
OTHER
U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia
UNKNOWN
Ospedale Generale Di Zona Moriggia-Pelascini
OTHER
Emanuele Cereda
OTHER
Responsible Party
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Emanuele Cereda
Co-Project Investigator
Principal Investigators
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Michela Barichella, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Parkinson, ASST Gaetano Pini-CTO di Milano
Locations
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Centro Parkinson, ASST Gaetano Pini-CTO
Milan, , Italy
Countries
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References
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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.
Other Identifiers
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184_2017
Identifier Type: -
Identifier Source: org_study_id
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