Research Article: Effects of boron citrate supplementation on cardiometabolic factors, inflammatory biomarkers and anthropometric measures in obese patients: study protocol for a randomised, double-blind clinical trial
Abstract:
Introduction Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. The efficacy and safety of boron citrate (BC), a novel therapeutic approach, in patients with obesity are not known. The current trial will take place to determine the effects of BC supplementation on cardiometabolic factors, inflammatory biomarkers, anthropometric measures and body composition in obese patients. Methods and analysis This double-blind, placebo-controlled, randomised clinical trial will involve 60 eligible obese participants aged 18–60 years. Participants will randomly be allocated to receive either BC capsules (containing 10?mg of boron) in the intervention group or placebo capsules (containing 10?mg of maltodextrin) in the placebo group for 12 weeks. Moreover, physical activity and dietary recommendations will be provided for both groups. To assess the dietary intakes of participants, a 3-day food record (2?days of the week and 1?day of the weekend) will be filled. Cardiometabolic factors, inflammatory biomarkers including tumour necrosis factor ?, C reactive protein, interleukin-6 and interleukin-10 levels, anthropometric measures and body composition will be assessed at the baseline and end of the intervention. The findings of this study will provide evidence for the effectiveness of BC in the management of obesity. Ethics and dissemination There are so far no reported adverse effects associated with the use of boron. This trial was approved by the Ethics Committee of Tabriz University of Medical Sciences (approval number: IR.TBZMED.REC.1401.350). Positive as well as negative findings will be published in peer-reviewed journals. Trial registration number IRCT20220806055624N1.
Introduction:
Obesity, which typically refers to excess body fat, has emerged as a major public health issue. Obesity is associated with numerous comorbidities, including hypertension, dyslipidaemia, type 2 diabetes, cardiovascular disease and non-alcoholic fatty liver disease. 1 Existing data show that the prevalence of obesity is rising. 2 In 2016, more than 20% of the world’s population were obese. 3 In this way, Iran is not exempt from this issue. About 40.3% and 19.2% of Iranians were overweight or obese, respectively,…
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