Gut Microbial Substrate Switch to Improve Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Peripheral insulin sensitivity
研究概览
简要总结
Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.
The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.
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
- 否
入选标准
- •Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 < 35 kg/m2)
排除标准
- •Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
- •Gastroenterological diseases or abdominal surgery;
- •Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- •Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day;
- •Plans to lose weight or following of a hypocaloric diet;
- •Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
- •Intensive exercise training more than three hours a week;
- •Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
- •Regular use of laxation products;
- •Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- •Follow a vegetarian diet.
- •Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)
- •The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck
- •Claustrophobia
研究组 & 干预措施
Placebo
isocaloric placebo
干预措施: Placebo (Dietary Supplement)
whole fiber product
15 g for 2 weeks, followed by 30 g for 10 weeks
干预措施: Whole fiber product (Dietary Supplement)
结局指标
主要结局
Peripheral insulin sensitivity
时间窗: Before and 12 week after the start of the intervention
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
次要结局
- In vitro microbial activity testing(Before and 12 week after the start of the intervention)
- Circulating metabolites such as glucose(Before and 12 week after the start of the intervention)
- Substrate oxidation (indirect calorimetry)(Before and 12 week after the start of the intervention)
- Circulating inflammatory markers such as TNF(Before and 12 week after the start of the intervention)
- Energy expenditure (indirect calorimetry)(Before and 12 week after the start of the intervention)
- Faecal microbiota composition and in vitro microbial activity testing(Before and 12 week after the start of the intervention)
- Circulating hormones such as insulin(Before and 12 week after the start of the intervention)
- body weight(Before and 12 week after the start of the intervention)
- body composition(Before and 12 week after the start of the intervention)
- liver fat content(Before and 12 week after the start of the intervention)
- hepatic and adipose tissue insulin sensitivity(Before and 12 week after the start of the intervention)
- Faecal and circulating SCFA(Before and 12 week after the start of the intervention)