PMID- 32670822 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231111 IS - 2225-4110 (Print) IS - 2225-4110 (Electronic) IS - 2225-4110 (Linking) VI - 10 IP - 3 DP - 2020 May TI - The synergistic effect of Citrus bergamia and Cynara cardunculus extracts on vascular inflammation and oxidative stress in non-alcoholic fatty liver disease. PG - 268-274 LID - 10.1016/j.jtcme.2020.02.004 [doi] AB - 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. CI - (c) 2020 Center for Food and Biomolecules, National Taiwan University. Production and hosting by Elsevier Taiwan LLC. FAU - Musolino, Vincenzo AU - Musolino V AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Gliozzi, Micaela AU - Gliozzi M AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Bombardelli, Ezio AU - Bombardelli E AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Nucera, Saverio AU - Nucera S AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Carresi, Cristina AU - Carresi C AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Maiuolo, Jessica AU - Maiuolo J AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Mollace, Rocco AU - Mollace R AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Paone, Sara AU - Paone S AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Bosco, Francesca AU - Bosco F AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Scarano, Federica AU - Scarano F AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Scicchitano, Miriam AU - Scicchitano M AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Macri, Roberta AU - Macri R AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Ruga, Stefano AU - Ruga S AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Zito, Maria Caterina AU - Zito MC AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Palma, Ernesto AU - Palma E AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Gratteri, Santo AU - Gratteri S AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Ragusa, Monica AU - Ragusa M AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. FAU - Volterrani, Maurizio AU - Volterrani M AD - San Raffaele IRCCS, Rome, Italy. FAU - Fini, Massimo AU - Fini M AD - San Raffaele IRCCS, Rome, Italy. FAU - Mollace, Vincenzo AU - Mollace V AD - Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy. AD - San Raffaele IRCCS, Rome, Italy. LA - eng PT - Journal Article DEP - 20200208 PL - Netherlands TA - J Tradit Complement Med JT - Journal of traditional and complementary medicine JID - 101605474 PMC - PMC7340872 OTO - NOTNLM OT - Bergamot polyphenols OT - Cynaropicrin OT - Endothelial impairment OT - NAFLD OT - T2DM OT - Vascular injury COIS- The authors declare no conflict of interest. EDAT- 2020/07/17 06:00 MHDA- 2020/07/17 06:01 PMCR- 2020/02/08 CRDT- 2020/07/17 06:00 PHST- 2019/12/05 00:00 [received] PHST- 2020/02/06 00:00 [revised] PHST- 2020/02/07 00:00 [accepted] PHST- 2020/07/17 06:00 [entrez] PHST- 2020/07/17 06:00 [pubmed] PHST- 2020/07/17 06:01 [medline] PHST- 2020/02/08 00:00 [pmc-release] AID - S2225-4110(19)31244-1 [pii] AID - 10.1016/j.jtcme.2020.02.004 [doi] PST - epublish SO - J Tradit Complement Med. 2020 Feb 8;10(3):268-274. doi: 10.1016/j.jtcme.2020.02.004. eCollection 2020 May.