Nutritional Support for Rehabilitation In Parkinsonism

Disability Physical Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124277
• Other study ID #: 184_2017
• Status: Completed
• Phase: N/A
• First received: April 14, 2017
• Last updated: February 12, 2018
• Start date: April 26, 2017
• Est. completion date: January 17, 2018

Study information

• Verified date: February 2018
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 17, 2018
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical
• Parkinsonian Disorders

Intervention

Dietary Supplement:
• 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.

Other:
• Control Group
Best local diet

Locations

Country	Name	City	State
Italy	Centro Parkinson, ASST Gaetano Pini-CTO	Milano

Sponsors (4)

Lead Sponsor	Collaborator
Emanuele Cereda	ASST Gaetano Pini-CTO, Ospedale Generale Di Zona Moriggia-Pelascini, U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status - distance walked during the six minutes walking test	Change in the distance walked during the six minutes walking test	30 days
Secondary	Functional status - timed up and go test	Change in timed up and go test	30 days
Secondary	Functional status - Berg balance scale	Change in Berg balance scale score	30 days
Secondary	Functional status - handgrip strength	Change in handgrip strength	30 days
Secondary	Functional status - gait speed	Change in gait speed (4 minutes walking test)	30 days
Secondary	Self-perceived functional status	Change in Self-assessment Parkinson's Disease Disability Scale	30 days
Secondary	Body weight	Change in body weight	30 days
Secondary	Muscle mass	Change in muscle mass	30 days
Secondary	Adverse events	Occurrence of adverse events	30 days
Secondary	Treatment continuation	Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale	30 days