An Exploratory Randomized Clinical Trial to Assess the Effects of Vitamin D and Leucine-Enriched Whey Protein Supplementation on Inflammaging and Gut Eubacterial Biomass in Cardiac Rehabilitation Patients
6 affiliations
- 1Dietetic and Clinical Nutrition Service, IRCCS Fondazione Don Carlo Gnocchi ETS, Via di Scandicci 269, 50143 Florence, Italy
- 2Department of Neurofarba, Section of Pharmacology and Toxicology, University of Florence, Viale Pieraccini 6, 50139 Florence, Italy
- 3Department of Life Sciences, Health and Health Professions, Link Campus University, 00165 Rome, Italy
- 4Department of Agriculture, Food, Environment and Forestry (DAGRI), University of Florence, Piazzale delle Cascine 18, 50144 Florence, Italy
- 5Cardiac Rehabilitation Unit, IRCCS Fondazione Don Carlo Gnocchi ETS, Via di Scandicci 269, 50143 Florence, Italy
- 6Department of Rehabilitation, IRCCS Fondazione Don Carlo Gnocchi ETS, Via di Scandicci 269, 50143 Florence, Italy
Abstract
Whey protein (WP) supplementation could affect low-grade inflammation (inflammaging) and gut microbiome dysbiosis, both of which play key roles in non-communicable diseases (NCDs). Twenty-seven cardiac rehabilitation patients were randomly allocated to two groups: the case group (CA) (n = 14) received 80 g/die vitamin D and leucine-enriched WP supplement, combined with a standard hospital diet, while the control group (CO, n = 13) received the standard hospital diet alone. Blood and stool samples were collected at baseline (T0) and after two weeks (T1). At T1, serum levels of interleukin 6 (IL-6) and C-reactive protein (CRP) significantly decreased in the CA group. Ferritin levels significantly decreased within both groups and between the two groups. No significant differences were observed for IL-1β, tumor necrosis factor-α (TNF-α), or IL-10. A clear difference in the bacterial intestinal microbiome composition between the case group at T1 (CAT1) and at T0 (CAT0), and control group at T0 (COT0) and at T1 (COT1), was observed. The eubacterial rpoB copy number, which was quantified by qPCR, significantly increased between CAT0 and CAT1, in contrast to the Lactobacillus spp. rpoB copy number. Our exploratory results showed that vitamin D and leucine-enriched WP supplementation could have a potential effect on chronic inflammation and gut microbiota composition in cardiac rehabilitation patients.
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BibTeX
@article{gheri2026exploratory,
title = {{An Exploratory Randomized Clinical Trial to Assess the Effects of Vitamin D and Leucine-Enriched Whey Protein Supplementation on Inflammaging and Gut Eubacterial Biomass in Cardiac Rehabilitation Patients}},
author = {Chiara Francesca Gheri and Maria Luisa Eliana Luisi and Laura Lucarini and Barbara Biffi and Sara Madiai and Angela Roccotelli and Renato Zipoli and Silvia Sgambellone and Gustavo Provensi and Claudio Macchi and Emanuela Masini and Maria Teresa Ceccherini},
journal = {Biomolecules},
year = {2026},
month = oct,
doi = {10.3390/biom16101484},
url = {https://www.mdpi.com/2218-273X/16/10/1484},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - An Exploratory Randomized Clinical Trial to Assess the Effects of Vitamin D and Leucine-Enriched Whey Protein Supplementation on Inflammaging and Gut Eubacterial Biomass in Cardiac Rehabilitation Patients
AU - Chiara Francesca Gheri
AU - Maria Luisa Eliana Luisi
AU - Laura Lucarini
AU - Barbara Biffi
AU - Sara Madiai
AU - Angela Roccotelli
AU - Renato Zipoli
AU - Silvia Sgambellone
AU - Gustavo Provensi
AU - Claudio Macchi
AU - Emanuela Masini
AU - Maria Teresa Ceccherini
PY - 2026
DA - 2026/10/01
JO - Biomolecules
DO - 10.3390/biom16101484
UR - https://www.mdpi.com/2218-273X/16/10/1484
AB - Whey protein (WP) supplementation could affect low-grade inflammation (inflammaging) and gut microbiome dysbiosis, both of which play key roles in non-communicable diseases (NCDs). Twenty-seven cardiac rehabilitation patients were randomly allocated to two groups: the case group (CA) (n = 14) received 80 g/die vitamin D and leucine-enriched WP supplement, combined with a standard hospital diet, while the control group (CO, n = 13) received the standard hospital diet alone. Blood and stool samples were collected at baseline (T0) and after two weeks (T1). At T1, serum levels of interleukin 6 (IL-6) and C-reactive protein (CRP) significantly decreased in the CA group. Ferritin levels significantly decreased within both groups and between the two groups. No significant differences were observed for IL-1β, tumor necrosis factor-α (TNF-α), or IL-10. A clear difference in the bacterial intestinal microbiome composition between the case group at T1 (CAT1) and at T0 (CAT0), and control group at T0 (COT0) and at T1 (COT1), was observed. The eubacterial rpoB copy number, which was quantified by qPCR, significantly increased between CAT0 and CAT1, in contrast to the Lactobacillus spp. rpoB copy number. Our exploratory results showed that vitamin D and leucine-enriched WP supplementation could have a potential effect on chronic inflammation and gut microbiota composition in cardiac rehabilitation patients.
SN - 2218-273X
ER -