Clinical trial NCT03124277: Nutritional Support for Rehabilitation In 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability Physical
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: ASST Gaetano Pini-CTO
name: U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia
name: Ospedale Generale Di Zona Moriggia-Pelascini
First posted: 2017-04-21
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Functional status - distance walked during the six minutes walking test
timeFrame: 30 days
Secondary outcomes:
measure: Functional status - timed up and go test
timeFrame: 30 days
measure: Functional status - Berg balance scale
timeFrame: 30 days
measure: Functional status - handgrip strength
timeFrame: 30 days
measure: Functional status - gait speed
timeFrame: 30 days
measure: Self-perceived functional status
timeFrame: 30 days
measure: Body weight
timeFrame: 30 days
measure: Muscle mass
timeFrame: 30 days
measure: Adverse events
timeFrame: 30 days
measure: Treatment continuation
timeFrame: 30 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Centro Parkinson, ASST Gaetano Pini-CTO
Study officials:
affiliation: Centro Parkinson, ASST Gaetano Pini-CTO di Milano
name: Michela Barichella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.