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PROtein, LEucine And vitamin D Enhancing Rehabilitation (PRO-LEADER) in patients with Parkinson’s disease or parkinsonism: A RCT

M. Barichella, E. Cereda, G. Pinelli, L. Iorio, D. Caroli, I. Masiero, V. Ferri, E. Cassani, C. Bolliri, S. Caronni, P. Ortelli, D. Ferrazzoli, A. Maras, G. Riboldazzi, G. Frazzitta, G. Pezzoli (Milano, Italy)

Meeting: 2018 International Congress

Abstract Number: 426

Keywords: Parkinsonism, Rehabilitation

Session Information

Date: Saturday, October 6, 2018

Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment

Session Time: 1:45pm-3:15pm

Location: Hall 3FG

Objective: We evaluated the efficacy of a muscle-targeted nutritional support on the outcomes of a multidisciplinary intensive rehabilitation treatment (MIRT).

Background: Physical rehabilitation is an important strategy for treating motor disability in patients with Parkinson’s disease (PD) or parkinsonism. Studies in old adults with sarcopenia have shown that muscle mass and exercise-based treatments may be positively influenced by concomitant nutritional support but no evidence in parkinsonian syndrome – characterized by high rates of muscle dysfunction and low prevalence of sarcopenia – is available.

Methods: We conducted a pragmatic, randomized (1:1), controlled trial (NCT03124277) in patients suffering from PD or parkinsonism and undergoing a MIRT. Patients (n=150) received a standard hospital diet with or without a vitamin D and leucine-enriched whey protein-based nutritional supplement twice daily for 30 days. The primary efficacy end point was the increase in the distance walked during a 6-minute walking test (6MWT). Secondary outcome variables 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 a greater increase in the distance walked during a 6MWT (mean, 69.6 meters [95%CI, 60.7-78.6]) than no support (51.8 meters [95%CI, 37.0-66.7]): adjusted mean difference, 18.1 [95%CI, 0.9-35.3] meters; P=0.039). A significant effect was also found for the following secondary end points: 4-meter walking speed (0.07 m/s [95%CI, 0.01-0.13], P=0.032), TUG test (-1.1 s [95%CI, -2.2-0.0], P=0.046), and SMM (0.5 kg [95%CI, 0.0-1.0], P=0.029).

Conclusions: The consumption of a whey protein-based nutritional formula enriched with essential aminoacids and vitamin D improved the disability in patients with PD or parkinsonism and could be considered part of a MIRT.

To cite this abstract in AMA style:

M. Barichella, E. Cereda, G. Pinelli, L. Iorio, D. Caroli, I. Masiero, V. Ferri, E. Cassani, C. Bolliri, S. Caronni, P. Ortelli, D. Ferrazzoli, A. Maras, G. Riboldazzi, G. Frazzitta, G. Pezzoli. PROtein, LEucine And vitamin D Enhancing Rehabilitation (PRO-LEADER) in patients with Parkinson’s disease or parkinsonism: A RCT [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/protein-leucine-and-vitamin-d-enhancing-rehabilitation-pro-leader-in-patients-with-parkinsons-disease-or-parkinsonism-a-rct/. Accessed December 5, 2023.
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