Alternative and Complementary Medicine for Gastrointestinal and Liver Diseases Research Unit, Department of Physiology, Faculty of Medicine, Chulalongkorn University, Pathumwan, Bangkok, Thailand.
Center of Excellence in Hepatitis and Liver Cancer, Department of Biochemistry, Faculty of Medicine, Chulalongkorn University, Pathumwan, Bangkok, Thailand.
J Integr Complement Med. 2022 Nov;28(11):904-908. doi: 10.1089/jicm.2021.0362. Epub 2022 Sep 7.
Oligonol, an oligomerized-polyphenol from extract, has been shown to alleviate metabolic syndrome. The aim of this study was to evaluate the effects of oligonol in patients with nonalcoholic fatty liver disease (NAFLD). Adult patients with NAFLD defined by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) ≥11% were enrolled and then randomly assigned to receive either oligonol or placebo capsules. Primary endpoint was ≥30% reduction in MRI-PDFF at 24 weeks. Secondary outcomes were reductions in bodyweight, waist circumference, alanine transaminase, fasting blood sugar, and lipid profiles at week 24. Forty patients were enrolled ( = 20/group). Primary endpoint was achieved in 20% in the oligonol group and 15% in the placebo group ( = 0.50). The authors found a reduction in MRI-PDFF between weeks 0 and 24 in the oligonol group; however, the change was not different from the placebo group. Secondary outcomes were similar between two groups. Oligonol has not shown a significant therapeutic effect in NAFLD. Future studies with a longer duration of therapy might be needed to achieve the primary endpoint. Thai Clinical Trial Registry identification number: TCTR20200814001.
橄榄多酚,一种从 中提取的低聚物多酚,已被证明可缓解代谢综合征。本研究旨在评估橄榄多酚在非酒精性脂肪性肝病(NAFLD)患者中的作用。通过磁共振成像衍生质子密度脂肪分数(MRI-PDFF)≥11%诊断为 NAFLD 的成年患者入组,然后随机分配接受橄榄多酚或安慰剂胶囊治疗。主要终点为 24 周时 MRI-PDFF 至少降低 30%。次要结局为 24 周时体重、腰围、丙氨酸转氨酶、空腹血糖和血脂谱的降低。
共纳入 40 例患者(每组 20 例)。主要终点在橄榄多酚组的 20%和安慰剂组的 15%患者中达成(=0.50)。研究人员发现橄榄多酚组在 0 至 24 周时 MRI-PDFF 降低;然而,与安慰剂组相比,变化无差异。两组的次要结局相似。
橄榄多酚在 NAFLD 中未显示出显著的治疗效果。可能需要进行更长时间的治疗的未来研究来实现主要终点。
TCTR20200814001。