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临床试验/NCT06247020
NCT06247020已完成不适用

Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study

Federico II University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年2月24日最近更新:
适应症

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

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

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

rivellese angela

Full Professor

Federico II University

研究点 (2)

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