NCT02271776已完成不适用
The Effects of Galactooligosaccharide (GOS) on Peripheral Insulin Sensitivity and Body Weight Control in Obese Adults With Impaired Glucose Homeostasis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- systemic insulin sensitivity
研究概览
简要总结
Based on our hypothesis that orally administered GOS will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of a 12-week supplementation of GOS on peripheral insulin sensitivity and body weight control in obese adults with impaired glucose homeostasis.
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, Investigator)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese (BMI ≥ 28 kg/m2 < 40 kg/m2) insulin impaired men and post-menopausal women with impaired glucose tolerance (IGT: 2h plasma glucose during 75g OGTT 7.8-11.1 mmol/l) and/or impaired fasting glucose (plasma glucose ≥ 5.6 mmol/l) aged 45-70 years will be included in the study.
- •In addition, subjects have to be weight-stable for at least 3 months prior to participation (no change in bodyweight, i.e. < 3kg).
排除标准
- •diabetes mellitus
- •gastroenterological diseases or major abdominal surgery (allowed i.e.: appendectomy, cholecystectomy)
- •lactose intolerance and other digestive disorders
- •cardiovascular disease, cancer, liver or kidney malfunction (determined based on ALAT and creatinine levels, respectively)
- •disease with a life expectancy shorter than 5 years
- •abuse of products (alcohol consumption > 15 units/week, or any drugs)
- •excessive nicotine use defined as >20 cigarettes per day
研究组 & 干预措施
Galactooligosaccharide
Active Comparator
5g 3x per day for 12 weeks
干预措施: Galactooligosaccharide (Dietary Supplement)
maltodextrin
Placebo Comparator
3x per day for 12 weeks (isocaloric to intervention)
干预措施: maltodextrin (Dietary Supplement)
结局指标
主要结局
systemic insulin sensitivity
时间窗: change from baseline at 12 week supplementation
次要结局
- substrate oxidation and energy expenditure(change from baseline at 12 week supplementation)
- plasma markers of substrate and energy metabolism(change from baseline at week 1 and at 12 week supplementation)
- fecal and plasma SCFA concentrations(change from baseline at week 1 and at 12 week supplementation)
- fecal microbiota composition(change from baseline at week 1 and at 12 week supplementation)
- skeletal muscle and adipose tissue gen and protein expression(change from baseline at week 1 and at 12 week supplementation)
研究者
研究点 (1)
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