Brown Adipose Tissue as Nutrient Buffer Through Diet Induced Thermogenesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC Glucose
研究概览
简要总结
To test the hypothesis that active BAT improves metabolic health by buffering postprandial metabolites plasma metabolites and energy expenditure will be compared in volunteers with and without active BAT. Both groups will receive test meals with protein, fat and carbohydrates separately, so that the individual impacts of these macronutrients on diet induced thermogenesis and the buffering function of BAT can be derived. BAT biopsies will be taken before and after the test meals for molecular analysis.
详细描述
In this prospective interventional study healthy individuals will be screened for presence of active BAT: Maximal BAT activity will be achieved by a mild cold stimulus over 2 hous and quantified by 18F-FDG-PET/CT 30 min after injection of 75 MBq of 18F-FDG.
Individuals with FDG-PET positive BAT will be included as BAT-positive subjects (n=15) and individuals with absence of FDG-positive BAT will be included as BAT-negative subjects (n=15) and then take part in three study visits in random order.
During the study visits participants will consume a standardized isocaloric liquid meal consisting of A) glucose (OGTT) B) fat and C) protein.
Energy expenditure will be measured by indirect calorimetry before as well as hourly after the meal for 5 hours. Blood samples will be taken before and at 30 minute intervals after the meal for 5 hours for analysis of blood glucose, triglycerides, FAAs, representative amino acids, insulin and noradrenaline.
Subjects will undergo ultrasound-guided biopsy of the supraclavicular fat depot in the fasting state and after one of the test meals so that biopsies from 5 individuals in each group after each test meal will be obtained.
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
- 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 18.5 to 28 kg/m2
- •Able to give informed consent as documented by signature
排除标准
- •Concomitant medication other than prescription free analgesics (paracetamol and NSAID) and oral contraceptives
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus)
- •Hyper- or hypothyroidism
- •Smoker / habitual tobacco use
- •Weight change of >5% within 3 months prior to inclusion
- •Hypersensitivity to cold (e.g. Raynaud syndrome)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Enrolment into another study using ionizing radiation within the previous 12 months
- •Enrolment into another study including a pharmacological or nutritional intervention
- •Pregnancy or lactation
- •Lab parameters
- •Serum-Creatinine: above 1.5x upper limit of normal (ULN)
- •Glycated Hemoglobin (HbA1c): above 6.0%
- •Random plasma glucose >11 mM
结局指标
主要结局
AUC Glucose
时间窗: 1h before and 5 hours after nutritional intervention
Area under the curve (AUC) of glucose after the oral glucose load in participants with functional BAT as compared to participants without functional BAT
次要结局
- AUC triglycerides(1h before and 5 hours after nutritional intervention)
- AUC Branched chain amino acids(1h before and 5 hours after nutritional intervention)
- Diet induced thermogenesis(1h before and 5 hours after nutritional intervention)