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白藜芦醇在肥胖症中的减肥作用:对 ClinicalTrials.gov 中随机对照试验设计的评估。

Resveratrol for Weight Loss in Obesity: An Assessment of Randomized Control Trial Designs in ClinicalTrials.gov.

机构信息

Centre for Healthy Futures, Torrens University Australia, Pyrmont, NSW 2009, Australia.

Department of Pharmacy & Biomedical Sciences, La Trobe University, Bendigo, VIC 3550, Australia.

出版信息

Nutrients. 2022 Mar 29;14(7):1424. doi: 10.3390/nu14071424.

Abstract

Resveratrol is a polyphenol that may improve weight loss outcomes in obese individuals. However, assessing the effectiveness of resveratrol supplementations as an appropriate intervention for weight loss in obesity across randomized control trials (RCTs) has been complicated by variability in their design. This study aims to evaluate design elements across RCTs of resveratrol interventions in obesity with weight loss as an end-point outcome, as recorded in ClinicalTrials.gov. We found discrepancies in participant inclusion criteria (sample size, age ranges, sex, BMI, medical conditions), interventional design (delivery modalities, dosages, duration) and primary outcomes measured (anthropomorphic, blood biomarkers). We identified a near three-fold variation in study sample size, two-fold variation in minimum inclusion age, five modalities of therapeutic resveratrol delivery with interventional durations ranging from two weeks to six months. Weight loss was only identified as a primary outcome in three of the seven studies evaluated. In conclusion, heterogeneity in trial design using resveratrol suggests that weight-loss-related outcomes are difficult to interpret and cross-validate. Indeed, conclusions drawn from human studies have been inconsistent, which may be attributed to study design heterogeneity including major differences in sample population, age, sex, BMI, underlying health conditions and end-point measures.

摘要

白藜芦醇是一种多酚,可能会改善肥胖人群的减肥效果。然而,由于设计的变异性,评估白藜芦醇补充剂作为肥胖症减肥的适当干预措施的有效性在随机对照试验 (RCT) 中变得复杂。本研究旨在评估临床试验数据库中记录的肥胖症中以减肥为终点的白藜芦醇干预 RCT 的设计要素。我们发现参与者纳入标准(样本量、年龄范围、性别、BMI、疾病状况)、干预设计(给药方式、剂量、持续时间)和测量的主要结果(人体测量、血液生物标志物)存在差异。我们发现研究样本量的差异接近三倍,最小纳入年龄的差异两倍,五种治疗白藜芦醇给药方式,干预持续时间从两周到六个月不等。在评估的七项研究中,只有三项将体重减轻作为主要结果。总之,使用白藜芦醇的试验设计的异质性表明,与减肥相关的结果难以解释和交叉验证。事实上,从人体研究中得出的结论并不一致,这可能归因于研究设计的异质性,包括样本人群、年龄、性别、BMI、潜在健康状况和终点测量的主要差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c82a/9002514/eeb4db73ca43/nutrients-14-01424-g001.jpg

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