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Randomized Controlled Trial
. 2022 Oct 30;14(21):4566.
doi: 10.3390/nu14214566.

Effectiveness of a Novel Food Composed of Leucine, Omega-3 Fatty Acids and Probiotic Lactobacillus paracasei PS23 for the Treatment of Sarcopenia in Elderly Subjects: A 2-Month Randomized Double-Blind Placebo-Controlled Trial

Mariangela Rondanelli  1   2 , Clara Gasparri  3 , Gaetan Claude Barrile  3 , Santina Battaglia  4 , Alessandro Cavioni  3 , Riccardo Giusti  4 , Francesca Mansueto  3 , Alessia Moroni  3 , Fabrizio Nannipieri  4 , Zaira Patelli  3 , Claudia Razza  3 , Alice Tartara  3 , Simone Perna  5
Affiliations
Randomized Controlled Trial

Effectiveness of a Novel Food Composed of Leucine, Omega-3 Fatty Acids and Probiotic Lactobacillus paracasei PS23 for the Treatment of Sarcopenia in Elderly Subjects: A 2-Month Randomized Double-Blind Placebo-Controlled Trial

Mariangela Rondanelli et al. Nutrients. .

Abstract

Sarcopenia is a complex process characterized by a progressive decrease in muscle mass and strength. Various nutrients have been shown to be effective in supporting muscular performance. This randomized clinical trial aimed to evaluate the effectiveness of a 2-month administration of food for special medical purposes composed of omega-3 fatty acids (500 mg), leucine (2.5 g), and probiotic Lactobacillus paracasei PS23 (LPPS23), on appendicular lean mass (ALM), muscle performance, inflammatory status, and amino acid profile in sarcopenic patients. A total of 60 participants (aged 79.7 ± 4.8 years and a body mass index of 22.2 ± 2.1 kg/m2) were enrolled and randomly assigned to either intervention (n = 22) or placebo group (n = 28). Comparing the differences in effects between groups (intervention minus placebo effects), ALM increased significantly in the intervention group (p < 0.05), with no discernible change in the placebo group. Similarly, significant differences were also observed for the Tinetti scale (+2.39 points, p < 0.05), the SPPB total score (+2.22 points, p < 0.05), and the handgrip strength (4.09 kg, p < 0.05). Visceral adipose tissue significantly decreased in the intervention group compared to the placebo group at 60 days −0.69 g (95% CI: −1.09, 0.29) vs. 0.27 g (95% CI: −0.11, 0.65), groups difference −0.96 (95% CI: −1.52, 0.39, p = 0.001). A statistically significant increase in levels of valine, leucine, isoleucine, and total amino acid profiles was observed in the intervention group compared with the placebo group at 60 days (p = 0.001). When taken together, these beneficial effects may be attributed to the innovative composition of this special medical-purpose food which could be considered for the treatment of sarcopenia in the elderly.

Keywords: Lactobacillus paracasei PS23; leucine; omega-3 fatty acids; probiotic; sarcopenia.

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Conflict of interest statement

S.B., R.G. and F.N. are employed by Abiogen Pharma. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study Design.
Figure 2
Figure 2
Flowchart of the study.
Figure 3
Figure 3
Body composition changes after 30 and 60 days of treatment.
Figure 4
Figure 4
Between-group effects on the amino acids profile.
See this image and copyright information in PMC

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