The effects of exercise and low-calorie diets compared with low-calorie diets alone on health: a protocol for systematic reviews and meta-analyses of controlled clinical trials

Abstract Background: Exercise and weight loss diets are two independent non-pharmaceutical strategies used to improve several aspects of body composition and health. We plan to systematically review controlled clinical trials investigating weight loss diets alone compared to weight loss diets in conjunction with exercise on energy intake, body weight, body composition, cardiometabolic risk factors, sex hormones, and mental health. Methods and analysis: PubMed/MEDLINE, EMBASE, ISI (Web of Science), Scopus, and Google Scholar will be searched to retrieve potential controlled clinical trials investigating the effects of exercise in conjunction with weight-loss diets compared with weight-loss diets alone on energy intake, body weight and composition (fat mass, fat-free mass), anthropometrics (waist circumference), cardiometabolic markers, sex hormones [testosterone, estradiol, and sex hormone binding globulin (SHBG)], liver and kidney enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), uric acid, blood urea nitrogen (BUN), glomerular filtration rate (GFR), quality of life and depression in adults. The weighted mean difference (WMD) and its corresponding 95% confidence intervals (CIs) will be derived using random effects model. Several subgroup analyses such as gender, age, BMI, exercise protocol, and diet used for weight loss will be conducted to explore possible sources of heterogeneity. Publication bias will be explored by inspecting funnel plots and by conducting asymmetry tests. Overall quality of the evidence will be assessed by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool.Discussion: We envisage that this systematic review and meta-analysis will provide valuable information regarding the effectiveness of adding exercise to weight-loss diets. No primary data is going to be collected, therefore ethical approval is not required. The resulting manuscripts will be disseminated in peer-reviewed journals and at international and national conferences.Systematic review registration: The study protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO, Registration ID: CRD42020173434).