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A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease
BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk irrespective of conventional risk factors. The role of gut-liver interaction is implicated in its development. We investigated the effects of VSL#3(®) probiotic supplementation on biomarkers of car...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8015038/ https://www.ncbi.nlm.nih.gov/pubmed/33794784 http://dx.doi.org/10.1186/s12876-021-01660-5 |
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author | Chong, Pui Lin Laight, David Aspinall, Richard J. Higginson, Antony Cummings, Michael H. |
author_facet | Chong, Pui Lin Laight, David Aspinall, Richard J. Higginson, Antony Cummings, Michael H. |
author_sort | Chong, Pui Lin |
collection | PubMed |
description | BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk irrespective of conventional risk factors. The role of gut-liver interaction is implicated in its development. We investigated the effects of VSL#3(®) probiotic supplementation on biomarkers of cardiovascular risk and liver injury in patients with NAFLD. METHODS: A randomised, double-blinded, placebo-controlled, proof-of-concept study was undertaken. Patients with NAFLD were randomly allocated to take 2 sachets VSL#3(®) probiotic or placebo twice daily for 10 weeks. Measurements of endothelial function (digital photoplethysmography, sVCAM-1 and cGMP), oxidative stress (glutathione ratio and LHP), inflammation (hsCRP), insulin resistance (HOMA-IR) and liver injury [transaminases, fibrosis risk score and acoustic structure quantification (ASQ)] were undertaken before and after intervention. Difference in baseline characteristics between the treatment groups was analysed using independent t-test or Mann Whitney U test for non-parametric data. Independent t-test was used to compare the outcomes at the end of the study between the two treatment groups. Wilcoxon Signed Rank test was used to determine the difference in fibrosis risk scores before and after treatment. Spearman’s correlation was used to determine any association between cardiovascular and hepatic markers at baseline. RESULTS: Thirty-five patients completed the study (28 males and 7 females) with a mean age of 57 ± 8 years, body mass index of 32.6 ± 5.0 kg/m(2) and a relatively short duration of NAFLD (median duration 0.3 IQR 2.0 years). No significant difference was observed in biomarkers of cardiovascular risk and liver injury following VSL#3(®) supplementation. Significant correlations were noted between sVCAM-1 and hsCRP (rho = 0.392, p = 0.01), and HOMA-IR and AST (rho = 0.489, p < 0.01) at baseline. CONCLUSIONS: This is the first study to evaluate the effect of VSL#3(®) on ASQ in patients with NAFLD. VSL#3(®) did not significantly improve markers of cardiovascular risk and liver injury in patients with NAFLD. However, the study supports an association between endothelial dysfunction and inflammation in patients with NAFLD and suggests that NAFLD is linked with insulin resistance. Trial registration: ISRCTN05474560 (https://doi.org/10.1186/ISRCTN05474560) Registered 9 August 2012 (retrospectively registered). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12876-021-01660-5. |
format | Online Article Text |
id | pubmed-8015038 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80150382021-04-01 A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease Chong, Pui Lin Laight, David Aspinall, Richard J. Higginson, Antony Cummings, Michael H. BMC Gastroenterol Research Article BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk irrespective of conventional risk factors. The role of gut-liver interaction is implicated in its development. We investigated the effects of VSL#3(®) probiotic supplementation on biomarkers of cardiovascular risk and liver injury in patients with NAFLD. METHODS: A randomised, double-blinded, placebo-controlled, proof-of-concept study was undertaken. Patients with NAFLD were randomly allocated to take 2 sachets VSL#3(®) probiotic or placebo twice daily for 10 weeks. Measurements of endothelial function (digital photoplethysmography, sVCAM-1 and cGMP), oxidative stress (glutathione ratio and LHP), inflammation (hsCRP), insulin resistance (HOMA-IR) and liver injury [transaminases, fibrosis risk score and acoustic structure quantification (ASQ)] were undertaken before and after intervention. Difference in baseline characteristics between the treatment groups was analysed using independent t-test or Mann Whitney U test for non-parametric data. Independent t-test was used to compare the outcomes at the end of the study between the two treatment groups. Wilcoxon Signed Rank test was used to determine the difference in fibrosis risk scores before and after treatment. Spearman’s correlation was used to determine any association between cardiovascular and hepatic markers at baseline. RESULTS: Thirty-five patients completed the study (28 males and 7 females) with a mean age of 57 ± 8 years, body mass index of 32.6 ± 5.0 kg/m(2) and a relatively short duration of NAFLD (median duration 0.3 IQR 2.0 years). No significant difference was observed in biomarkers of cardiovascular risk and liver injury following VSL#3(®) supplementation. Significant correlations were noted between sVCAM-1 and hsCRP (rho = 0.392, p = 0.01), and HOMA-IR and AST (rho = 0.489, p < 0.01) at baseline. CONCLUSIONS: This is the first study to evaluate the effect of VSL#3(®) on ASQ in patients with NAFLD. VSL#3(®) did not significantly improve markers of cardiovascular risk and liver injury in patients with NAFLD. However, the study supports an association between endothelial dysfunction and inflammation in patients with NAFLD and suggests that NAFLD is linked with insulin resistance. Trial registration: ISRCTN05474560 (https://doi.org/10.1186/ISRCTN05474560) Registered 9 August 2012 (retrospectively registered). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12876-021-01660-5. BioMed Central 2021-04-01 /pmc/articles/PMC8015038/ /pubmed/33794784 http://dx.doi.org/10.1186/s12876-021-01660-5 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Chong, Pui Lin Laight, David Aspinall, Richard J. Higginson, Antony Cummings, Michael H. A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease |
title | A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease |
title_full | A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease |
title_fullStr | A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease |
title_full_unstemmed | A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease |
title_short | A randomised placebo controlled trial of VSL#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease |
title_sort | randomised placebo controlled trial of vsl#3(®) probiotic on biomarkers of cardiovascular risk and liver injury in non-alcoholic fatty liver disease |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8015038/ https://www.ncbi.nlm.nih.gov/pubmed/33794784 http://dx.doi.org/10.1186/s12876-021-01660-5 |
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