Nutritional Support for Rehabilitation In Parkinsonism

Not Applicable

Completed

• Conditions: Disability Physical
• Interventions: Other: Control Group; Dietary Supplement: Fortifit®

• Registration Number: NCT03124277
• Lead Sponsor: Emanuele Cereda

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-21
• Study Start: 2017-04-26
• Primary Completion: 2018-01-17
• Study Completion: 2018-01-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Group	Best local diet
Fortifit®	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.

Primary Outcome Measures

Name	Time	Method
Functional status - distance walked during the six minutes walking test	30 days	Change in the distance walked during the six minutes walking test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centro Parkinson, ASST Gaetano Pini-CTO; 🇮🇹 Milano, Italy