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Nutritional Support for Rehabilitation In Parkinsonism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03124277
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : February 14, 2018
Sponsor:
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

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

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124277


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emanuele Cereda, Co-Project Investigator, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT03124277     History of Changes
Other Study ID Numbers: 184_2017
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents