Scientific Direction, IRCCS INRCA, Ancona, Italy.
Cardiology Unit, IRCCS INRCA, Via della Montagnola 81, 60131, Ancona, Italy.
Trials. 2020 Jul 6;21(1):616. doi: 10.1186/s13063-020-04551-4.
Elevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression. Increasing evidence suggests that cholesterol-lowering and inflammation-lowering nutraceuticals are useful in the management of moderate hypercholesterolemia. Here, we describe the study protocol of a clinical trial aimed to evaluate the cholesterol and inflammatory lowering effect of an innovative dietary supplement (BruMeChol™, Mivell S.r.l., Italy), composed of a mixture of extracts of bergamot and olive fruits in association with vitamin K2 in subjects with mild hypercholesterolemia.
The study was planned as a randomized, double-blind, placebo-controlled, parallel group clinical trial for 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy. A total of 125 subjects (age ≥ 40 years) with mild hypercholesterolemia (total serum cholesterol levels ≥ 200 and ≤ 250 mg/dl) will be recruited. Intervention arm participants will take one capsule of dietary supplement two times a day, 15 min before the main meal. Control arm participants will receive one capsule of placebo in the same way. The dietary supplement capsule contains the following ingredients: phytosterols, flavonoid-rich extract of bergamot fruit (Citrus bergamia), flavonoid-rich extract of olive fruit (Olea europaea), and vitamin K2. Participants will undergo a medical evaluation and chemical-clinical examinations, which include lipid profile, glycemia, biomarkers of renal, liver and cardiac/muscular functions, interleukins (IL 6, IL-32, IL-37, and IL-38), and innovative mediators of inflammation such as inflamma-miRs (miR-21 and miR-146a), at baseline, and after 6 and 12 weeks of treatment. The decrease in total cholesterol levels and inflammatory biomarkers will be the primary and secondary endpoints of the study.
This protocol study, planned to verify the effects of BruMeChol™ dietary supplementation in subjects with mild hypercholesterolemia, could also contribute to new study designs for next large-scale multicenter clinical trials.
Australian New Zealand Clinical Trials Registry: ACTRN12619000170123 . Retrospectively registered on 5 February 2019.
升高的胆固醇水平和全身炎症被认为是心血管疾病（CVD）发展和进展的相关危险因素。越来越多的证据表明，降低胆固醇和降低炎症的营养保健品可用于治疗中度高胆固醇血症。在这里，我们描述了一项临床试验的研究方案，该试验旨在评估一种创新的膳食补充剂（BruMeChol™，Mivell S.r.l.，意大利）对轻度高胆固醇血症患者的胆固醇和炎症降低作用，该补充剂由佛手柑和橄榄果提取物的混合物与维生素 K2 联合组成。
该研究计划在意大利安科纳的 IRCCS INRCA 心脏病学系进行为期 12 周的随机、双盲、安慰剂对照、平行组临床试验。共招募 125 名（年龄≥40 岁）轻度高胆固醇血症（总血清胆固醇水平≥200 且≤250mg/dl）患者。干预组参与者将每天服用两次膳食补充剂胶囊，每次 15 分钟在主餐前。对照组参与者将以同样的方式服用安慰剂胶囊。膳食补充剂胶囊包含以下成分：植物甾醇、富含佛手柑果实的类黄酮提取物（Citrus bergamia）、富含橄榄果实的类黄酮提取物（Olea europaea）和维生素 K2。参与者将进行医疗评估和化学临床检查，包括血脂谱、血糖、肾功能、肝功能和心脏/肌肉功能生物标志物、白细胞介素（IL-6、IL-32、IL-37 和 IL-38）以及炎症的创新介质，如 inflamma-miRs（miR-21 和 miR-146a），在基线时以及治疗 6 周和 12 周后。总胆固醇水平和炎症生物标志物的降低将是该研究的主要和次要终点。
这项计划研究旨在验证 BruMeChol™膳食补充剂对轻度高胆固醇血症患者的作用，也可能有助于新的研究设计，用于未来的大型多中心临床试验。
澳大利亚新西兰临床试验注册中心：ACTRN12619000170123。于 2019 年 2 月 5 日回顾性注册。
