Objective: Objective. To evaluate whether the use of a whey protein-based nutritional formula enriched with essential aminoacids – particularly leucine – and vitamin D have a beneficial effect on functional exercise-based rehabilitation.

Background: Background. Physical rehabilitation is an important strategy for treating motor disability in patients suffering from Parkinson’s disease (PD) or parkinsonism. Muscle dysfunction is highly prevalent in this patient population and previous studies in old adults have shown that the outcome of exercise-based treatments may be positively influenced by concomitant nutritional support.

Methods: Patients and Methods. We designed a randomized, controlled trial. Patients suffering from PD or parkinsonism and scheduled for a multidisciplinary intensive rehabilitation treatment will be randomized (1:1) to receive standard hospital diet with or without a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 30 days. The primary efficacy end point will be the increase in the distance walked during a 6-minute walking test. Secondary outcome variables will be: timed up and go test, Berg balance scale, 4-meter walking speed, Self-assessment Parkinson’s Disease Disability Scale and body composition (muscle mass).

Results: Results. In absence of preliminary data on this topic, considering an effect size of 0.5 (clinically meaningful according to Cohen), the sample size sufficient to have a power of 80% to detect a significant difference in the primary outcome measure with a two-tailed type-I error of 5%, we would need at least 64 patients per group. After assuming 10% withdrawal, we planned to enroll 140 patients (70 per treatment group).

Conclusions: Conclusion. Positive data from this trial would offer an effective adjuvant treatment options for patients with PD or parkinsonism undergoing a multidisciplinary intensive rehabilitation treatment.

References: 1. Barichella M, Cereda E, Cassani E, Pinelli G, Iorio L, Ferri V, Privitera G, Pasqua M, Valentino A, Monajemi F, Caronni S, Lignola C, Pusani C, Bolliri C, Faierman SA, Lubisco A, Frazzitta G, Petroni ML, Pezzoli G. Dietary habits and neurological features of Parkinson’s disease patients: Implications for practice. Clin Nutr. 2016 Jul 5. pii: S0261-5614(16)30155-8.

2. Barichella M, Pinelli G, Iorio L, Cassani E, Valentino A, Pusani C, Ferri V, Bolliri C, Pasqua M, Pezzoli G, Frazzitta G, Cereda E. Sarcopenia and Dynapenia in Patients With Parkinsonism. J Am Med Dir Assoc. 2016 Jul 1;17(7):640-6.

3. Frazzitta G, Maestri R, Bertotti G, Riboldazzi G, Boveri N, Perini M, Uccellini D, Turla M, Comi C, Pezzoli G, Ghilardi MF. Intensive rehabilitation treatment in early Parkinson’s disease: a randomized pilot study with a 2-year follow-up. Neurorehabil Neural Repair. 2015 Feb;29(2):123-31..

4. Fontanesi C, Kvint S, Frazzitta G, Bera R, Ferrazzoli D, Di Rocco A, Rebholz H, Friedman E, Pezzoli G, Quartarone A, Wang HY, Ghilardi MF. Intensive Rehabilitation Enhances Lymphocyte BDNF-TrkB Signaling in Patients With Parkinson’s Disease. Neurorehabil Neural Repair. 2016 Jun;30(5):411-8.

5. Rimmelzwaan LM, van Schoor NM, Lips P, Berendse HW, Eekhoff EM. Systematic Review of the Relationship between Vitamin D and Parkinson’s Disease. J Parkinsons Dis. 2016;6(1):29-37.

6. Cereda E, Barichella M, Pedrolli C, Pezzoli G. Low-protein and protein-redistribution diets for Parkinson’s disease patients with motor fluctuations: a systematic review. Mov Disord. 2010 Oct 15;25(13):2021-34.

7. Rondanelli M, Klersy C, Terracol G, Talluri J, Maugeri R, Guido D, Faliva MA, Solerte BS, Fioravanti M, Lukaski H, Perna S. Whey protein, amino acids, and vitamin D supplementation with physical activity increases fat-free mass and strength, functionality, and quality of life and decreases inflammation in sarcopenic elderly. Am J Clin Nutr. 2016 Mar;103(3):830-40.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/rehabilitation-program-with-or-without-a-whey-protein-based-nutritional-support-enriched-with-essential-aminoacids-and-vitamin-d-in-patients-with-parkinsons-disease-or-parkinsonism-study-des/