A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers: a Meal Test Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Postprandial plasma glucose at 60 min as a function of gut microbial richness
研究概览
简要总结
Individuals eating identical meals present high variability in post-meal blood glucose response making comparisons challenging. This study evaluates in 40 healthy and fasted participants whether the postprandial glucose response upon a standardized breakfast is dependent on gut microbial richness. Gastric emptying rate, intestinal transit time, insulin, appetite hormones and measures of the intestinal microbiome and fermentation will also be analyzed in the context of postprandial glucose metabolism.
详细描述
Elevated blood glucose levels constitute a major risk factor for pre-diabetic and diabetic patients. Postprandial glucose tests have been used for decades to monitor and compare glucose responses. Yet, individuals eating identical meals present high variability in post-meal blood glucose response making comparisons challenging. A recent landmark study showed that the inter-individual variation of postprandial glucose responses was associated with multiple person-specific factors including faecal microbiome factors. Gut microbial richness has for a long time been considered a hallmark of gut health and stability. Furthermore, microbial richness has been associated with colonic transit time, which together with the gastric emptying rate appear to be major determinants of the initial glycaemic response to carbohydrate-containing meals. Therefore, the aim of the study is to investigate whether postprandial glucose responses are associated with gut microbial richness, as well as secondary measures including gastric emptying rate, intestinal transit time and gut microbial composition and fermentation.
In an acute-meal study, 40 healthy fasted participants will consume a standardized breakfast including one tablet of paracetamol (for estimating gastric emptying rate) and 300 mL of juice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI < 27
- •Willing to eat lentils, tomatoes, spaghetti, bread, butter, strawberry jam, and drink juice
- •Known ability to tolerate paracetamol
- •No current use of medication (oral contraceptive pill and mild antidepressants is allowed)
- •Did not take antibiotics, diarrhoea inhibitors and laxatives in the 6 previous months
- •Willing to collect and deliver a faecal sample on the intervention day
- •Willing to eat corn and fill out a self-reported corn-intestinal transit time questionnaire
- •Willing to consume a paracetamol tablet (500 mg paracetamol)
排除标准
- •Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
- •Pregnant or lactating women
- •Suffering from irritable bowel disease (IBS), small intestine bacterial overgrowth (SIBO) or inflammatory bowel disease (IBD)
- •Current chronic or infectious disease
- •Current diagnosis of diabetes
- •Blood donations within 3 months before participating in the current trial or participation in other scientific experiments
- •Frequent intake of painkillers (paracetamol)
研究组 & 干预措施
Paracetamol and breakfast
One tablet of paracetamol (500 mg) and a standardized breakfast will be consumed within 15 minutes one morning upon 10 hours of fasting
干预措施: Standardized breakfast (Other)
结局指标
主要结局
Postprandial plasma glucose at 60 min as a function of gut microbial richness
时间窗: 60 min
We test whether there is an inverse association between baseline fecal gut microbial richness and postprandial plasma glucose at 60 min after a standardised meal including 0.5 g paracetamol
次要结局
- Postprandial glucose 0-60 min as a function of gastric emptying(0, 15, 30, 60 min)
- Time to plasma glucose maximum concentration as a function of gut microbial diversity/richness(0, 15, 30, 60, 90 and 120 min)
- Postprandial plasma glucose AUC as a function of gut microbial richness/diversity(0, 15, 30, 60, 90 and 120 min)
- Maximum plasma glucose concentration as a function of gut microbial diversity/richness(0, 15, 30, 60, 90 and 120 min)
- Gastric emptying and postprandial glucose 0-120 min(0, 15, 30, 60, 90 and 120 min)
- Fasting (baseline) plasma glucose as a function of gut microbial diversity/richness(0 min)
- Postprandial plasma glucose extremes as a function of gut microbial diversity/richness(0, 15, 30, 60, 90 and 120 min)
研究者
Professor Lars Ove Dragsted
Professor
University of Copenhagen