Nutritional Support for Rehabilitation In Parkinsonism

• 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

• Functional status - distance walked during the six minutes walking test [30 days]: Change in the distance walked during the six minutes walking test

Secondary outcomes

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

Sex: All

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

• Results publication: 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 31278117

• Michela Barichella, MD, Principal investigator, Centro Parkinson, ASST Gaetano Pini-CTO di Milano