Nutritional Support for Rehabilitation In Parkinsonism

A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Patients With Parkinsonism Undergoing Rehabilitation Treatment: a Randomized Trial

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

Study Overview

• Status: Completed
• Conditions: Disability Physical
• Intervention / Treatment: Dietary supplement: Fortifit®; Other: Control Group

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • Centro Parkinson, ASST Gaetano Pini-CTO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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	Other: Control Group; Best local diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status - distance walked during the six minutes walking test	Change in the distance walked during the six minutes walking test	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Emanuele Cereda
• Collaborators: Ospedale Generale Di Zona Moriggia-Pelascini; ASST Gaetano Pini-CTO; U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia
• Investigators: Principal Investigator: Michela Barichella, MD, Centro Parkinson, ASST Gaetano Pini-CTO di Milano

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): January 17, 2018
• Study Completion (Actual): January 17, 2018

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Parkinsonian Disorders
• Other Study ID Numbers: 184_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No