NCT03124277

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

April 14, 2017

Last Update Submit

April 29, 2025

Conditions

Disability Physical

Outcome Measures

Primary Outcomes (1)

  • Functional status - distance walked during the six minutes walking test

    Change in the distance walked during the six minutes walking test

    30 days

Secondary Outcomes (9)

  • Functional status - timed up and go test

    30 days

  • Functional status - Berg balance scale

    30 days

  • Functional status - handgrip strength

    30 days

  • Functional status - gait speed

    30 days

  • Self-perceived functional status

    30 days

  • +4 more secondary outcomes

Study Arms (2)

Fortifit®

EXPERIMENTAL

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®

Control group

OTHER

Best local diet

Other: Control Group

Interventions

Fortifit®DIETARY_SUPPLEMENT

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.

Fortifit®
Control GroupOTHER

Best local diet

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease o parkinsonism
  • admission for physical rehabilitation
  • Informed consent

You may not qualify if:

  • 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
  • Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
  • Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Parkinson, ASST Gaetano Pini-CTO

Milan, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31278117DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Michela Barichella, MD

    Centro Parkinson, ASST Gaetano Pini-CTO di Milano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Project Investigator

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 21, 2017

Study Start

April 26, 2017

Primary Completion

January 17, 2018

Study Completion

January 17, 2018

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

IT(1)