Effect of the Natural Sweeteners Erythritol and Xylitol on Vascular Function in Obese Volunteers: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Central arterial stiffness measured by sonography
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. A pilot study recently undertaken in the US (Flint N, 2014) has shown that diabetics profit from a daily intake of erythritol, as this natural sweetener enhances the elasticity of the blood vessels. In this trial, investigators aim to examine whether this effect can be found in a non-diabetic but obese cohort, and whether also xylitol improves vascular function.
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
- Double (Participant, Outcomes Assessor)
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
- •Smoking and drug abuse
- •Arterial hypertension with antihypertensive treatment
- •Dyslipidaemia with statin therapy
- •Known chronic hepatic disease (NASH, hepatitis).
- •Known renal disease: kidney failure
- •Pregnancy
- •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
Central arterial stiffness measured by sonography
时间窗: Change from baseline to 5 weeks after intake of polyol
次要结局
- Glucose tolerance measured by oral glucose tolerance test(Change from baseline to 5 weeks after intake of polyol)