Abstract

BackgroundTaurine (Tau) is involved in many biochemical functions such as regulation of glucose and lipid metabolism, enhancement of energy expenditure, anti-inflammatory effects and appetite control. The most important effect of Tau in obesity is its direct effect on adipose tissue. Some evidence has shown an impaired FGF (fibroblast growth factor) 19 and 21 biosyntheses in obesity. Besides the effects of eicosapentaenoic acid on serum FGF concentrations, the effect of other nutrients on FGFs is not clear. Since obesity as an important health problem is rising around the world and on the other side, Tau biosynthesis is reduced by adipose-tissue-derived factors in obesity, the effects of Tau and a weight-loss diet on obesity need to be investigated further.MethodsWe will conduct an 8-week. double-blind, parallel-group, randomized controlled clinical trial to investigate the effect of Tau supplementation on fasting serum levels of FGFs, β-Klotho co-receptor, some biochemical indices and body composition in 50 obese women aged between 18 and 49 years on a weight-loss diet.DiscussionWe will determine the other advantages of a weight-loss diet on new metabolic risk factors. Since Tau may regulate adipose-tissue-derived factors and a weight-loss diet can promote the useful effects of Tau supplementation; for the first time, the effects of a weight-loss diet along with Tau supplementation on these variables will be assessed.Trial registrationIran Clinical Trials Registry, ID: IRCT20131125015542N2. Registered on 24 November 2018.

Highlights

  • Obesity rates are rising around the world

  • FGF19 and FGF21 link to a unique dual receptor complex consisting of β-klotho and activate tyrosine kinase Fibroblast growth factors (FGFs) receptors (FGFR1–4) via a low-affinity interaction with heparan sulfate glycosaminoglycans (HSGAGs). β-klotho links to those and facilitates FGFR activation. β-klotho mainly expresses in metabolic organs including liver, adipose tissue and pancreas [5, 6]

  • Since serum FGF concentration is associated with visceral obesity [7] and the effect of Tau supplementation on serum FGF concentration is not clear, we decided to conduct a randomized controlled clinical trial (RCT) investigating the effect of Tau supplementation on fasting serum levels of fibroblast growth factors (FGF19, FGF21), β-Klotho coreceptor, some of the metabolic risk factors and body composition in obese women on a weight-loss diet

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Summary

Methods

Design and setting We will be performed a double-blind, parallel-group, clinical RCT. The sample size was calculated based on the effect of Tau supplementation on changes in hs-CRP in obese people that was conducted by Rosa et al [12]. It was computed by considering 95% confidence interval and 80% power (α = 0.05 and β = 0.2). All individuals will be included in the RCT if they meet the inclusion criteria and are willing to participate in the study to achieve the estimated sample size. Randomization and blinding Eligible subjects will be divided and stratified based on age (within 10-year intervals) randomly into two groups including control (standard weight-loss group + taking placebo, n = 25) and intervention (standard weight-loss group + Tau supplementation, n = 25).

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