NCT05378295已完成不适用
Personalized Microbial Substrates to Prevent Type 2 Diabetes
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
- 44
- 试验地点
- 1
- 主要终点
- Peripheral insulin sensitivity
研究概览
简要总结
In this project the investigators intend to study the therapeutic potential of a personalized fibre mixture in individuals at high risk of developing T2DM, and aim to address the following key objectives:
- To investigate whether a mixture of fermentable fibres, which differ in DP and side chains, will stimulate a broad range of SCFA-producing bacterial genera, resulting in enhanced chronic SCFA production throughout the whole colon with a large variation between individuals;
- To unravel whether providing personalized fibre mixtures, selected based on the individuals' initial microbiota and capacity for SCFA production is crucial to successfully improve host insulin sensitivity and metabolic health
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese insulin resistant/prediabetic participants (age 30-70 y, BMI ≥ 28 kg/m2 < 40 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.
研究组 & 干预措施
isocaloric fermentable oligosaccaride
Active Comparator
isocaloric fermentable oligosaccaride
干预措施: Fermentable oligosaccharide (Dietary Supplement)
Personalized fiber mixture
Experimental
12 g for 2 weeks, followed by 24 g for 10 weeks
干预措施: Personalized fiber mixture (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 (m-value) as assessed by a hyperinsulinaemic-euglycemic clamp
次要结局
- Substrate oxidation (indirect calorimetry)(Before and 12 week after the start of the intervention)
- circulating SCFA(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)
- fat mass(Before and 12 week after the start of the intervention)
- Energy expenditure (indirect calorimetry)(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)
- body weight(Before and 12 week after the start of the intervention)
- Faecal SCFA(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)
- body fat percentage(Before and 12 week after the start of the intervention)
- lean mass(Before and 12 week after the start of the intervention)
- visceral fat(Before and 12 week after the start of the intervention)
研究者
研究点 (1)
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