Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome

Michela Barichella, Emanuele Cereda, Giovanna Pinelli, Laura Iorio, Diana Caroli, Irene Masiero, Valentina Ferri, Erica Cassani, Carlotta Bolliri, Serena Caronni, Marcello Maggio, Paola Ortelli, Davide Ferrazzoli, Antonios Maras, Giulio Riboldazzi, Giuseppe Frazzitta, Gianni Pezzoli

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: We evaluated the efficacy of muscle-targeted nutritional support on the functional outcomes of multidisciplinary intensive rehabilitation treatment (MIRT) in patients with Parkinson disease (PD) or parkinsonism. METHODS: We conducted a pragmatic, bicentric, randomized (1:1), assessor-blind controlled trial (Protein, Leucine and Vitamin D Enhancing Rehabilitation [PRO-LEADER]; April 2017 to January 2018) in cognitively intact patients with PD or parkinsonism and undergoing a 30-day MIRT. Patients (n = 150) received a standard hospital diet with or without a whey protein-based nutritional supplement enriched with leucine and vitamin D twice daily. The primary efficacy endpoint was the increase in the distance walked during a 6-minute walking test (6MWT). Secondary endpoints were changes in 4-meter walking speed, Timed Up and Go test (TUG), Berg balance scale, handgrip strength, Self-assessment Parkinson's Disease Disability Scale, body weight, and skeletal muscle mass (SMM). RESULTS: Nutritional support resulted in greater increase in the distance walked during 6MWT (mean 69.6 meters [95% confidence interval (CI) 60.7-78.6]) than no support (51.8 meters [95% CI 37.0-66.7]): center-adjusted mean difference, 18.1 meters (95% CI 0.9-35.3) (p = 0.039). Further adjustment for changes in dopaminergic therapy and SMM yielded consistent results: mean difference, 18.0 meters (95% CI 0.7-35.2) (p = 0.043). A meaningful effect was also found for the following secondary endpoints: 4-meter walking speed (p = 0.032), TUG (p = 0.046), SMM, and SMM index (p = 0.029). Six patients discontinued the nutritional therapy due to mild side effects. CONCLUSION: The consumption of a whey protein-based nutritional formula enriched with leucine and vitamin D with MIRT improved lower extremity function and preserved muscle mass in patients with PD or parkinsonism.Clinicaltrials.gov IDENTIFIER: NCT03124277. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with parkinsonism undergoing intensive rehabilitation, a whey protein-based nutritional formula enriched with leucine and vitamin D increased distance walked on the 6MWT.

Original languageEnglish
Pages (from-to)e485-e496
JournalNeurology
Volume93
Issue number5
DOIs
Publication statusPublished - Jul 30 2019

ASJC Scopus subject areas

  • Clinical Neurology

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    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. (2019). Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome. Neurology, 93(5), e485-e496. https://doi.org/10.1212/WNL.0000000000007858