Nutritional Support for Rehabilitation In Parkinsonism

• ClinicalTrials.gov Identifier: NCT03124277
• Recruitment Status: Completed
• First Posted: April 21, 2017
• Last Update Posted: February 14, 2018
• Sponsor: Emanuele Cereda
• Collaborators: ASST Gaetano Pini-CTO; U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia; Ospedale Generale Di Zona Moriggia-Pelascini
• Information provided by (Responsible Party): Emanuele Cereda, IRCCS Policlinico S. Matteo

Study Description

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

Condition or disease	Intervention/treatment	Phase
Disability Physical	Dietary Supplement: Fortifit®; Other: Control Group	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 26, 2017
• Actual Primary Completion Date: January 17, 2018
• Actual Study Completion Date: January 17, 2018

Arms and Interventions

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.
Control group; Best local diet	Other: Control Group; Best local diet

Outcome Measures

Primary Outcome Measures :

1. Functional status - distance walked during the six minutes walking test [ Time Frame: 30 days ]
   Change in the distance walked during the six minutes walking test

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

Centro Parkinson, ASST Gaetano Pini-CTO

Milano, Italy

Sponsors and Collaborators

Emanuele Cereda

ASST Gaetano Pini-CTO

U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia

Ospedale Generale Di Zona Moriggia-Pelascini

Investigators

• Principal Investigator: Michela Barichella, MD; Centro Parkinson, ASST Gaetano Pini-CTO di Milano

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Emanuele Cereda, Co-Project Investigator, IRCCS Policlinico S. Matteo
• ClinicalTrials.gov Identifier: NCT03124277
• Other Study ID Numbers: 184_2017
• First Posted: April 21, 2017
• Last Update Posted: February 14, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders