Nutritional Support for Rehabilitation In Parkinsonism

Emanuele Cereda

Status: Completed

Conditions: Disability Physical

Treatments: Dietary Supplement: Fortifit®; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03124277

184_2017

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Fortifit®

Experimental group

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.

Treatment:

Dietary Supplement: Fortifit®

Control group

Other group

Description:

Best local diet

Treatment:

Other: Control Group