Department of Medical and Surgical Science, University Magna Græcia, 88100, Catanzaro, Italy.
Department of Clinical and Experimental Medicine, University Magna Greæcia, Catanzaro, Italy.
J Transl Med. 2022 Aug 19;20(1):377. doi: 10.1186/s12967-022-03579-1.
Currently, there is no approved medication for non-alcoholic fatty liver disease management. Pre-clinical and clinical studies showed that several bioactive molecules in plants or foods (i.e., curcumin complex, bergamot polyphenol fraction, artichoke leaf extract, black seed oil, concentrate fish oil, picroliv root, glutathione, S-adenosyl-L-methionine and other natural ingredients) have been associated with improved fatty liver disease. Starting from these evidences, our purpose was to evaluate the effects of a novel combination of abovementioned nutraceuticals as a treatment for adults with fatty liver disease.
A total of 140 participants with liver steatosis were enrolled in a randomized, double-blind, placebo controlled clinical trial. The intervention group received six softgel capsules daily of a nutraceutical (namely Livogen Plus®) containing a combination of natural bioactive components for 12 weeks. The control group received six softgel capsules daily of a placebo containing maltodextrin for 12 weeks. The primary outcome measure was the change in liver fat content (CAP score). CAP score, by transient elastography, serum glucose, lipids, transaminases, and cytokines were measured at baseline and after intervention.
After adjustment for confounding variables (i.e., CAP score and triglyceride at baseline, and changes of serum γGT, and vegetable and animal proteins, cholesterol intake at the follow-up), we found a greater CAP score reduction in the nutraceutical group rather than placebo (- 34 ± 5 dB/m vs. - 20 ± 5 dB/m, respectively; p = 0.045). The CAP score reduction (%) was even greater in those with aged 60 or less, low baseline HDL-C, AST reduction as well as in men.
Our results showed that a new combination of bioactive molecules as nutraceutical was safe and effective in reducing liver fat content over 12 weeks in individuals with hepatic steatosis. Trial registration ISRCTN, ISRCTN70887063. Registered 03 August 2021-retrospectively registered, https://doi.org/10.1186/ISRCTN70887063.
目前，尚无治疗非酒精性脂肪性肝病的批准药物。临床前和临床研究表明，植物或食物中的几种生物活性分子（即姜黄素复合物、佛手柑多酚部分、朝鲜蓟叶提取物、黑种草籽油、浓缩鱼油、白藜芦醇根、谷胱甘肽、S-腺苷甲硫氨酸和其他天然成分）与改善脂肪肝疾病有关。基于这些证据，我们的目的是评估上述营养保健品的新型组合作为治疗成人脂肪肝的疗效。
共纳入 140 名患有肝脂肪变性的参与者，进行了一项随机、双盲、安慰剂对照临床试验。干预组每天服用 6 粒软胶囊，该软胶囊含有天然生物活性成分的组合，用于治疗 12 周；对照组每天服用 6 粒软胶囊，该软胶囊含有麦芽糊精，用于治疗 12 周。主要观察指标是肝脂肪含量的变化（CAP 评分）。通过瞬时弹性成像、血清葡萄糖、血脂、转氨酶和细胞因子，在基线和干预后测量 CAP 评分。
在调整混杂变量（即基线时的 CAP 评分和甘油三酯，以及随访时血清 γGT、植物性和动物性蛋白质、胆固醇摄入量的变化）后，我们发现营养保健品组的 CAP 评分降低幅度大于安慰剂组（分别为-34±5dB/m 与-20±5dB/m，p=0.045）。在年龄在 60 岁或以下、基线 HDL-C 较低、AST 降低以及男性中，CAP 评分降低的百分比更大。
我们的结果表明，一种新型生物活性分子组合作为营养保健品，在 12 周内安全有效地降低了肝脂肪含量。试验注册 ISRCTN，ISRCTN70887063。2021 年 8 月 3 日注册-回顾性注册，https://doi.org/10.1186/ISRCTN70887063。
