Nutritional Support for Rehabilitation In Parkinsonism
Primary Purpose
Disability Physical
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fortifit®
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Disability Physical
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
Sites / Locations
- Centro Parkinson, ASST Gaetano Pini-CTO
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Fortifit®
Control group
Arm Description
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.
Best local diet
Outcomes
Primary Outcome Measures
Functional status - distance walked during the six minutes walking test
Change in the distance walked during the six minutes walking test
Secondary Outcome Measures
Functional status - timed up and go test
Change in timed up and go test
Functional status - Berg balance scale
Change in Berg balance scale score
Functional status - handgrip strength
Change in handgrip strength
Functional status - gait speed
Change in gait speed (4 minutes walking test)
Self-perceived functional status
Change in Self-assessment Parkinson's Disease Disability Scale
Body weight
Change in body weight
Muscle mass
Change in muscle mass
Adverse events
Occurrence of adverse events
Treatment continuation
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Full Information
NCT ID
NCT03124277
First Posted
April 14, 2017
Last Updated
February 12, 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
1. Study Identification
Unique Protocol Identification Number
NCT03124277
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
January 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability Physical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fortifit®
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
Best local diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Fortifit®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Best local diet
Primary Outcome Measure Information:
Title
Functional status - distance walked during the six minutes walking test
Description
Change in the distance walked during the six minutes walking test
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Functional status - timed up and go test
Description
Change in timed up and go test
Time Frame
30 days
Title
Functional status - Berg balance scale
Description
Change in Berg balance scale score
Time Frame
30 days
Title
Functional status - handgrip strength
Description
Change in handgrip strength
Time Frame
30 days
Title
Functional status - gait speed
Description
Change in gait speed (4 minutes walking test)
Time Frame
30 days
Title
Self-perceived functional status
Description
Change in Self-assessment Parkinson's Disease Disability Scale
Time Frame
30 days
Title
Body weight
Description
Change in body weight
Time Frame
30 days
Title
Muscle mass
Description
Change in muscle mass
Time Frame
30 days
Title
Adverse events
Description
Occurrence of adverse events
Time Frame
30 days
Title
Treatment continuation
Description
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michela Barichella, MD
Organizational Affiliation
Centro Parkinson, ASST Gaetano Pini-CTO di Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Parkinson, ASST Gaetano Pini-CTO
City
Milano
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31278117
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.
Results Reference
derived
Learn more about this trial
Nutritional Support for Rehabilitation In Parkinsonism
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