Resveratrol for Weight Loss in Obesity: An Assessment of Randomized Control Trial Designs in ClinicalTrials.gov.
Ashley Brett HillsleyVanessa ChinAmy LiCraig S McLachlanPublished in: Nutrients (2022)
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.
Keyphrases
- weight loss
- bariatric surgery
- roux en y gastric bypass
- gastric bypass
- weight gain
- glycemic control
- randomized controlled trial
- phase iii
- healthcare
- body mass index
- double blind
- obese patients
- phase ii
- single cell
- endothelial cells
- public health
- clinical trial
- metabolic syndrome
- placebo controlled
- study protocol
- insulin resistance
- adipose tissue
- climate change
- high fat diet induced
- pluripotent stem cells