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The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease
BACKGROUND AND AIM: Non-Alcoholic Fatty Liver Disease (NAFLD) represents a risk factor for cardiovascular diseases. NAFLD is worsened by the simultaneous occurrence of type 2 diabetes mellitus (T2DM) causing an enhancement of inflammatory and fibrotic processes. Although insulin resistance appears t...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340872/ https://www.ncbi.nlm.nih.gov/pubmed/32670822 http://dx.doi.org/10.1016/j.jtcme.2020.02.004 |
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author | Musolino, Vincenzo Gliozzi, Micaela Bombardelli, Ezio Nucera, Saverio Carresi, Cristina Maiuolo, Jessica Mollace, Rocco Paone, Sara Bosco, Francesca Scarano, Federica Scicchitano, Miriam Macrì, Roberta Ruga, Stefano Zito, Maria Caterina Palma, Ernesto Gratteri, Santo Ragusa, Monica Volterrani, Maurizio Fini, Massimo Mollace, Vincenzo |
author_facet | Musolino, Vincenzo Gliozzi, Micaela Bombardelli, Ezio Nucera, Saverio Carresi, Cristina Maiuolo, Jessica Mollace, Rocco Paone, Sara Bosco, Francesca Scarano, Federica Scicchitano, Miriam Macrì, Roberta Ruga, Stefano Zito, Maria Caterina Palma, Ernesto Gratteri, Santo Ragusa, Monica Volterrani, Maurizio Fini, Massimo Mollace, Vincenzo |
author_sort | Musolino, Vincenzo |
collection | PubMed |
description | BACKGROUND AND AIM: Non-Alcoholic Fatty Liver Disease (NAFLD) represents a risk factor for cardiovascular diseases. NAFLD is worsened by the simultaneous occurrence of type 2 diabetes mellitus (T2DM) causing an enhancement of inflammatory and fibrotic processes. Although insulin resistance appears the link between NAFLD and T2DM, current pharmacological treatments of T2DM failed to produce relevant benefits in preventing T2DM-related liver dysfunction. In this randomized, double blind, placebo-controlled clinical study, we evaluated the effect of Bergacyn, an innovative formulation originating from the combination of Bergamot Polyphenolic Fraction (BPF) and Cynara cardunculus (CyC). EXPERIMENTAL PROCEDURE: 80 adult patients with a history of at least 12 months of T2DM and NAFLD received orally BPF (300 mg/daily) Cyc (300 mg/daily), separately or formulated in combination 50/50% (Bergacyn; 300 mg/daily), or placebo all containing 300 mg of bergamot albedo fibers micronized and co-grinded as excipients. RESULTS AND CONCLUSION: Serum measurements and liver ultrasound analyses showed that concomitant administration of BPF and CyC produced significant improvement of NAFLD biomarkers in patients with T2DM. This effect was associated with a substantial reduction of oxidative stress/inflammatory biomarkers, thus contributing to a significant improvement of NO-mediated reactive vasodilation. Furthermore, the effect of Bergacyn showed a synergistic effect of both extracts, thus suggesting that this peculiar formulation represents a novel therapeutic strategy to counteract vascular inflammation and endothelial dysfunction in patients suffering from T2DM and NAFLD. Further studies in larger cohort of diabetic patients are required to better identify the potential of Bergacyn on metabolic disorders accompanying T2DM and NAFLD. |
format | Online Article Text |
id | pubmed-7340872 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-73408722020-07-14 The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease Musolino, Vincenzo Gliozzi, Micaela Bombardelli, Ezio Nucera, Saverio Carresi, Cristina Maiuolo, Jessica Mollace, Rocco Paone, Sara Bosco, Francesca Scarano, Federica Scicchitano, Miriam Macrì, Roberta Ruga, Stefano Zito, Maria Caterina Palma, Ernesto Gratteri, Santo Ragusa, Monica Volterrani, Maurizio Fini, Massimo Mollace, Vincenzo J Tradit Complement Med Non-Alcoholic Fatty Liver Disease (NAFLD) BACKGROUND AND AIM: Non-Alcoholic Fatty Liver Disease (NAFLD) represents a risk factor for cardiovascular diseases. NAFLD is worsened by the simultaneous occurrence of type 2 diabetes mellitus (T2DM) causing an enhancement of inflammatory and fibrotic processes. Although insulin resistance appears the link between NAFLD and T2DM, current pharmacological treatments of T2DM failed to produce relevant benefits in preventing T2DM-related liver dysfunction. In this randomized, double blind, placebo-controlled clinical study, we evaluated the effect of Bergacyn, an innovative formulation originating from the combination of Bergamot Polyphenolic Fraction (BPF) and Cynara cardunculus (CyC). EXPERIMENTAL PROCEDURE: 80 adult patients with a history of at least 12 months of T2DM and NAFLD received orally BPF (300 mg/daily) Cyc (300 mg/daily), separately or formulated in combination 50/50% (Bergacyn; 300 mg/daily), or placebo all containing 300 mg of bergamot albedo fibers micronized and co-grinded as excipients. RESULTS AND CONCLUSION: Serum measurements and liver ultrasound analyses showed that concomitant administration of BPF and CyC produced significant improvement of NAFLD biomarkers in patients with T2DM. This effect was associated with a substantial reduction of oxidative stress/inflammatory biomarkers, thus contributing to a significant improvement of NO-mediated reactive vasodilation. Furthermore, the effect of Bergacyn showed a synergistic effect of both extracts, thus suggesting that this peculiar formulation represents a novel therapeutic strategy to counteract vascular inflammation and endothelial dysfunction in patients suffering from T2DM and NAFLD. Further studies in larger cohort of diabetic patients are required to better identify the potential of Bergacyn on metabolic disorders accompanying T2DM and NAFLD. Elsevier 2020-02-08 /pmc/articles/PMC7340872/ /pubmed/32670822 http://dx.doi.org/10.1016/j.jtcme.2020.02.004 Text en © 2020 Center for Food and Biomolecules, National Taiwan University. Production and hosting by Elsevier Taiwan LLC. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Non-Alcoholic Fatty Liver Disease (NAFLD) Musolino, Vincenzo Gliozzi, Micaela Bombardelli, Ezio Nucera, Saverio Carresi, Cristina Maiuolo, Jessica Mollace, Rocco Paone, Sara Bosco, Francesca Scarano, Federica Scicchitano, Miriam Macrì, Roberta Ruga, Stefano Zito, Maria Caterina Palma, Ernesto Gratteri, Santo Ragusa, Monica Volterrani, Maurizio Fini, Massimo Mollace, Vincenzo The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease |
title | The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease |
title_full | The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease |
title_fullStr | The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease |
title_full_unstemmed | The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease |
title_short | The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease |
title_sort | synergistic effect of citrus bergamia and cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease |
topic | Non-Alcoholic Fatty Liver Disease (NAFLD) |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340872/ https://www.ncbi.nlm.nih.gov/pubmed/32670822 http://dx.doi.org/10.1016/j.jtcme.2020.02.004 |
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