Skip to main content
OpenTrials
Completed

NCT Number: NCT03124277

Nutritional Support for Rehabilitation In Parkinsonism

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Disability Physical

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Parkinson, ASST Gaetano Pini-CTO

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control Group

Other

Best local diet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Emanuele Cereda

Other

Collaborators

  • ASST Gaetano Pini-CTO
  • Ospedale Generale Di Zona Moriggia-Pelascini
  • U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2017
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.