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
Institute of Research for Food Safety & Health, Department of Health Sciences, University "Magna Graecia" of Catanzaro, Nutramed Scarl and, Italy.
San Raffaele IRCCS, Rome, Italy.
J Tradit Complement Med. 2020 Feb 8;10(3):268-274. doi: 10.1016/j.jtcme.2020.02.004. eCollection 2020 May.
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 (CyC).
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.
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.
非酒精性脂肪性肝病（NAFLD）是心血管疾病的一个危险因素。2型糖尿病（T2DM）的同时发生会使NAFLD恶化，导致炎症和纤维化进程加剧。尽管胰岛素抵抗似乎是NAFLD和T2DM之间的联系，但目前T2DM的药物治疗未能在预防T2DM相关肝功能障碍方面产生显著益处。在这项随机、双盲、安慰剂对照的临床研究中，我们评估了Bergacyn的效果，Bergacyn是一种由佛手柑多酚组分（BPF）和（CyC）组合而成的创新制剂。
80名有至少12个月T2DM和NAFLD病史的成年患者口服BPF（每日300毫克）、CyC（每日300毫克），单独服用或按50/50%组合配方（Bergacyn；每日300毫克），或服用安慰剂，所有制剂均含有300毫克经微粉化和共研磨的佛手柑白瓤纤维作为辅料。
血清检测和肝脏超声分析表明，BPF和CyC联合给药可使T2DM患者的NAFLD生物标志物显著改善。这种效果与氧化应激/炎症生物标志物的大幅降低相关，从而有助于显著改善NO介导的反应性血管舒张。此外，Bergacyn的效果显示出两种提取物的协同作用，因此表明这种特殊配方代表了一种对抗T2DM和NAFLD患者血管炎症和内皮功能障碍的新型治疗策略。需要在更大规模的糖尿病患者队列中进行进一步研究，以更好地确定Bergacyn对伴随T2DM和NAFLD的代谢紊乱的潜在作用。
