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.

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.

Publication types

  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Amino Acids, Essential / therapeutic use
  • Body Weight
  • Cholecalciferol / therapeutic use
  • Dietary Proteins / therapeutic use
  • Dietary Supplements
  • Female
  • Food, Fortified
  • Humans
  • Leucine / therapeutic use*
  • Male
  • Middle Aged
  • Muscle, Skeletal*
  • Nutritional Support / methods*
  • Parkinson Disease / physiopathology
  • Parkinson Disease / rehabilitation*
  • Parkinsonian Disorders / physiopathology
  • Parkinsonian Disorders / rehabilitation
  • Physical Functional Performance*
  • Treatment Outcome
  • Vitamins / therapeutic use*
  • Walk Test
  • Walking Speed
  • Whey Proteins / therapeutic use*

Substances

  • Amino Acids, Essential
  • Dietary Proteins
  • Vitamins
  • Whey Proteins
  • Cholecalciferol
  • Leucine

Associated data

  • ClinicalTrials.gov/NCT03124277