CHU Sainte-Justine Centre de Recherche, Montreal, Québec, Canada.
CHU Sainte-Justine, Montreal, Québec, Canada.
BMJ Open. 2024 Jan 30;14(1):e074882. doi: 10.1136/bmjopen-2023-074882.
Non-alcoholic fatty liver disease (NAFLD) is increasingly prevalent in obese adolescents. Increased systemic inflammation and decreased gut microbial diversity linked to obesity affect the liver and are also associated with cardiovascular diseases in adulthood. However, NAFLD and vascular alterations are reversible.
This pilot study evaluated the feasibility of a prospective open-label randomised controlled trial evaluating the effects of polyphenols on NAFLD and vascular parameters in obese adolescents. Children aged 12-18 years with hepatic steatosis (n=60) will be recruited. The participants will be randomised with a 1:1 allocation ratio to receive polyphenol supplementation one time per day for 8 weeks along with the clinician-prescribed treatment (group B, n=30) or to continue the prescribed treatment without taking any polyphenols (group A, n=30). The outcome measures will be collected from both the groups at day 1 before starting polyphenol supplementation, at day 60 after 8 weeks of supplementation and at day 120, that is, 60 days after supplementation. The changes in hepatic steatosis and vascular parameters will be measured using liver and vascular imaging. Furthermore, anthropometric measures, blood tests and stool samples for gut microbiome analysis will be collected. After evaluating the study's feasibility, we hypothesise that, as a secondary outcome, compared with group A, the adolescents in group B will have improved NAFLD, vascular parameters, systemic inflammation and gut microbiome.
This study is approved by Health Canada and the hospital ethics. Participants and their parents/tutors will both provide consent. Trial results will be communicated to the collaborating gastroenterologists who follow the enrolled participants. Abstracts and scientific articles will be submitted to high-impact radiological societies and journals.
gov ID: NCT03994029. Health Canada authorisation referral number: 250 811. Protocole version 13, 2 June 2023.
NCT03994029.
非酒精性脂肪性肝病（NAFLD）在肥胖青少年中越来越普遍。与肥胖相关的全身性炎症增加和肠道微生物多样性减少会影响肝脏，并与成年人心血管疾病有关。然而，NAFLD 和血管改变是可以逆转的。
这项前瞻性开放标签随机对照试验评估了多酚对肥胖青少年 NAFLD 和血管参数影响的可行性。将招募 60 名年龄在 12-18 岁之间有肝脂肪变性的儿童。参与者将按照 1:1 的比例随机分配，每天接受一次多酚补充剂治疗 8 周，同时接受临床医生规定的治疗（B 组，n=30）或继续接受规定的治疗而不服用任何多酚（A 组，n=30）。将在开始多酚补充前的第 1 天（第 0 天）、补充 8 周后的第 60 天（第 60 天）以及补充后第 120 天（第 120 天）收集两组的结果测量值。将使用肝脏和血管成像来测量肝脂肪变性和血管参数的变化。此外，将收集人体测量学指标、血液测试和粪便样本进行肠道微生物组分析。在评估研究的可行性后，我们假设，作为次要结果，与 A 组相比，B 组的青少年的 NAFLD、血管参数、全身性炎症和肠道微生物组将得到改善。
本研究已获得加拿大卫生部和医院伦理委员会的批准。参与者及其父母/监护人将同时提供同意。试验结果将传达给参与研究的合作胃肠病学家。摘要和科学文章将提交给高影响力的放射学会和期刊。
gov ID：NCT03994029. 加拿大卫生部授权参考号：250 811. 第 13 版方案，2023 年 6 月 2 日。
NCT03994029。
