Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Plasma glucose
研究概览
简要总结
Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. In particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1 secretion, suggesting a possible role in the modulation of glucose metabolism. However, to date, very few randomized controlled trials (RCTs) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. To date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index: 25-30 kg/m2
排除标准
- •type 2 diabetes,
- •treatment with antibiotics within the past 3 months
- •history of gastrointestinal diseases (Inflammatory bowel disease, Crohn's disease, malabsorption etc )
- •cardiovascular events (myocardial infarction or stroke) during the 6-12 months prior to the study
- •thyroid disorders not controlled by drug therapy,
- •kidney (creatinine >1.7 mg/dl or proteinuria) and liver diseases (ALT/AST >twice the upper limits)
- •anaemia (Hb <12 g /dl)
- •pregnancy or breastfeeding,
- •celiac disease, cancer or any other chronic disease
结局指标
主要结局
Plasma glucose
时间窗: one week
The primary outcome of the study is the improvement of the glucose response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weight
次要结局
- Plasma insulin(one week)
研究者
rivellese angela
Full Professor
Federico II University
