丁酸钠补充对减肥饮食中肥胖个体 PGC-1α、PPARα 和 UCP-1 基因表达水平、GLP-1 血清水平、代谢参数和人体测量指数的影响：一项三盲、随机、安慰剂对照临床试验的研究方案。
The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial.
机构信息
Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Nutrition and Metabolic Diseases Research Center, Clinical Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
出版信息
Trials. 2023 Aug 1;24(1):489. doi: 10.1186/s13063-022-06891-9.
BACKGROUND
Obesity is a multifaceted disease characterized by an abnormal accumulation of adipose tissue. Growing evidence has proposed microbiota-derived metabolites as a potential factor in the pathophysiology of obesity and related metabolic conditions over the last decade. As one of the essential metabolites, butyrate affects several host cellular mechanisms related to appetite sensations and weight control. However, the effects of butyrate on obesity in humans have yet to be studied. Thus, the present study was aimed to evaluate the effects of sodium butyrate (SB) supplementation on the expression levels of peroxisome proliferator activated-receptor (PPAR) gamma coactivator-1α (PGC-1α), PPARα and uncoupling protein 1 (UCP1) genes, serum level of glucagon-like peptide (GLP1), and metabolic parameters, as well as anthropometric indices in obese individuals on a weight loss diet.
METHODS
This triple-blind randomized controlled trial (RCT) will include 50 eligible obese subjects aged between 18 and 60 years. Participants will be randomly assigned into two groups: 8 weeks of SB (600 mg/day) + hypo-caloric diet or placebo (600 mg/day) + hypo-caloric diet. At weeks 0 and 8, distinct objectives will be pursued: (1) PGC-1α, PPARα, and UCP1 genes expression will be evaluated by real-time polymerase chain reaction; (2) biochemical parameters will be assayed using enzymatic methods; and (3) insulin and GLP1 serum level will be assessed by enzyme-linked immunosorbent assay kit.
DISCUSSION
New evidence from this trial may help fill the knowledge gap in this realm and facilitate multi-center clinical trials with a substantially larger sample size.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials: IRCT20190303042905N2 . Registered on 31 January 2021.
背景
肥胖是一种多方面的疾病，其特征是脂肪组织的异常积累。在过去的十年中，越来越多的证据表明，微生物衍生代谢物是肥胖及其相关代谢疾病病理生理学的一个潜在因素。作为一种必需代谢物，丁酸盐影响与食欲感觉和体重控制相关的几种宿主细胞机制。然而，丁酸盐对人类肥胖的影响尚未得到研究。因此，本研究旨在评估丁酸钠（SB）补充对过氧化物酶体增殖物激活受体（PPAR）γ共激活因子-1α（PGC-1α）、PPARα和解偶联蛋白 1（UCP1）基因表达水平、血清胰高血糖素样肽（GLP1）水平和代谢参数以及肥胖个体在减肥饮食下的人体测量指数的影响。
方法
这项三盲随机对照试验（RCT）将包括 50 名年龄在 18 至 60 岁之间的合格肥胖受试者。参与者将被随机分为两组：8 周 SB（600mg/天）+低热量饮食或安慰剂（600mg/天）+低热量饮食。在第 0 周和第 8 周，将进行以下不同的目标研究：（1）通过实时聚合酶链反应评估 PGC-1α、PPARα 和 UCP1 基因表达；（2）使用酶法测定生化参数；（3）通过酶联免疫吸附测定试剂盒评估胰岛素和 GLP1 血清水平。
讨论
该试验的新证据可能有助于填补这一领域的知识空白，并促进具有更大样本量的多中心临床试验。
试验注册
伊朗临床试验注册中心：IRCT20190303042905N2。于 2021 年 1 月 31 日注册。
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