Elucidating the Role of Human Small Intestine Microbiota in Interpersonal Differences in GLYcemic Responses Upon Consumption of Food Products: A Proof of Principle Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- postprandial glucose response (iAUC) per test product
研究概览
简要总结
It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.
详细描述
Rationale: It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. Differences in small intestine microbiota are hypothesized to be key in explaining the interpersonal differences in glycemic responses.
Objective
To investigate the role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products.
Study design: The subjects will wear a continuous glucose monitor during the screening and the study. First a screening (14 days in total) will take place with to choose the test products (2 out of 4) that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. Also an OGTT will be performed. The study will be a randomized cross-over trial with two test days (length of trial is 6 days in total). During the trial, the subjects will be intubated with a naso-jejunum catheter.
Study population: Twenty men or women (BMI≥25 kg/m2, 40-75 years old). Intervention (if applicable): Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test.
Main study parameters/endpoints: test (food) product-induced plasma glucose responses (iAUC), small intestine microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •BMI≥25 kg/m2
- •Age 40-75 years
- •Signed informed consent
排除标准
- •Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes type 1, a swallowing disorder, gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants;
- •Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
- •Use of antibiotics within 2 months of starting the study or planned during the study;
- •Use of medication that could influence the study results, such as diabetes treatment;
- •Use of pro- and prebiotic supplements;
- •Sensitive to medical skin adhesives;
- •Having an allergy or intolerance towards compounds in the test products;
- •Follows a vegan diet;
- •Excessive alcohol consumption (on average >21 glasses/week for men and >14 glasses/week for women);
- •Currently a research subject in another clinical trial;
- •Having blood vessels that are too difficult for inserting a cannula/blood drawing'
- •Having a hemoglobin level <8.5 mmol/l (men) or <7.5 mmol/l (women);
- •Being a blood donor during the duration of the study;
- •Not having a General Practitioner (GP);
- •Being an employee of Wageningen University, division Human Nutrition and Health.
结局指标
主要结局
postprandial glucose response (iAUC) per test product
时间窗: 0-120 minutes
iAUC glucose
small intestine microbiome
时间窗: at baseline
the relative composition (%) and the functional capacity (%) of the small intestine microbiota
次要结局
- blood total free fatty acids(0-240 minutes)
- macronutrients in the small intestinal aspirates(0-240 minutes)
- presence and production of (bacterial) degradation products in the small intestinal aspirates(0-240 minutes)
- blood insulin(0-240 minutes)
- blood glucagon(0-240 minutes)
- blood total triglycerides(0-240 minutes)
- blood HbA1c(0-240 minutes)
- blood glucose(0-240 minutes)
- Salivary α-amylase(0-240 minutes)
- Oral microbiome composition(baseline)
- digestive enzymes in the small intestinal aspirates(0-240 minutes)
- non-absorbable marker in the small intestinal aspirates(0-240 minutes)
- plasma gut hormones(0-240 minutes)
- breath 13C-lactosyl ureide(0-240 minutes)
- breath hydrogen(0-240 minutes)
- breath methane(0-240 minutes)
- Fecal microbiota composition(baseline)
研究者
Guido Hooiveld
Principal Investigator
Wageningen University