Effect of the Natural Sweeteners Erythritol and Xylitol on Gut Microbiota and Glucose Metabolism in Obese Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Glucose tolerance measured with oral glucose tolerance test
研究概览
简要总结
Sugar alcohols such as xylitol and erythritol are increasingly popular as sugar substitutes in the food industry and are also recommended to diabetic patients. Both substances are already in use in the food industry and are freely available. Since the 1970s, beneficial effects on oral health could be demonstrated as oral bacteria were influenced positively. Animal studies showed an increase in gut Clostridium perfringens after xylitol intake; certainly a non-desirable effect. However, studies on effects of erythritol and xylitol on the human gut microbiota are lacking so far. In this trial, investigators aim to examine whether gut microbiota and glucose tolerance can be influenced by polyol intake in a non-diabetic but obese cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese volunteers (BMI > 30kg/m2)
- •Aged 18- max. 55 years
- •Otherwise healthy.
排除标准
- •Known cardiovascular disease
- •Diabetes mellitus
- •Arterial Hypertension with medication
- •Dyslipidaemia with medication
- •Known chronic hepatic disease (NASH, hepatitis).
- •Known renal disease: kidney failure
- •Pregnancy
- •Intake of proton pump inhibitors (PPIs) on a regular basis
- •Intake of antibiotics within the last 3 months before inclusion
- •Intake of pro or prebiotics
- •Chronical diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract
- •Substance abuse, alcohol abuse.
- •Inability to follow procedures due to psychological disorders, dementia or insufficient knowledge of project language (German).
结局指标
主要结局
Glucose tolerance measured with oral glucose tolerance test
时间窗: change from baseline to 8 weeks after polyol intake
次要结局
- Human gut microbiota composition measured with metagenomic shotgun sequencing(change from baseline to 8 weeks after polyol intake)
- Gastrointestinal tolerance assessed by questionnaire(change from baseline to 8 weeks after polyol intake)
- Gut microbial-related metabolites in urine(change from baseline to 8 weeks after polyol intake)
- Gut microbial-related metabolites in feces(change from baseline to 8 weeks after polyol intake)