SEnsory stimulatioN aS A Driver of dieT-induced Thermogenesis - the SENSATION Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Diet-induced energy expenditure
研究概览
简要总结
This study aims to assess the influence of sensory stimulation on diet-induced energy expenditure by way of a clinical cross-over trial in 24 healthy participants either receiving a meal bolus with (orally) and without sensory stimulation (nasogastric-tube).
详细描述
Here, the investigators postulate sensory stimulation (i.e. the sight, smell, auditory and tactile properties, as well as the taste of food) to be drivers of diet induced thermogenesis, an insufficiently understood mechanism of body weight regulation. Research into this area to date has focused on macro-nutrient composition delivered unphysiologically (i.v. or in form of unpalatable solutions). Thereby neglecting the bulk of food-intake associated sensory stimulation and thus the contribution of the brain itself.
The investigators aim to gain insight into the role of sensory stimulation in this context by means of a cross-over proof-of concept exploratory clinical trial. Comparing 24 healthy human volunteers receiving a meal bolus with (orally) and without sensory stimulation (nasogastric-tube) by indirect calorimetry, tissue-adjacent temperature measurements and ex vivo analyses.
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
- 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
- •healthy volunteers of any gender
- •BMI between 18-25 kg/m2
- •age between 18 and 40 years
排除标准
- •concomitant medication except for prescription free analgetics (paracetamol, NSAIDs) and oral contraceptives
- •clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
- •allergy to local anaesthetic or any of the study meal ingredients
- •known or suspected non-compliance, drug or alcohol abuse
- •smoker / habitual tobacco use
- •habitual excessive alcohol consumption
- •inability to follow the procedures of the study
- •participation in another study with investigational drug within the 30 days preceding and during the present study
- •previous enrolment into the current study
- •enrolment of the investigator, his/her family members, employees and other dependent persons
- •uncontrolled hypo- or hyperthyroidism
- •pregnancy or lactation
研究组 & 干预措施
Sensory Deprivation
Administration of the same meal as for the sensory exposure visit by way of a nasogastric tube
干预措施: sensory deprivation (Procedure)
Sensory Exposure
Administration of a full meal orally
干预措施: sensory exposure (Procedure)
结局指标
主要结局
Diet-induced energy expenditure
时间窗: data will be collected from baseline (30 minutes before meal bolus administration) up to 300 minutes post-administration, divided into five segments: four 30-minute intervals and one 75-minute interval.
diet-induced thermogenesis as determined by indirect calorimetry measurements of VO2 in the sensory exposure condition (full meal) as compared to the sensory deprivation condition (same meal via nasogastric tube)
次要结局
- Skin temperature(data will be collected from baseline (60 minutes before meal bolus administration) up to 300 minutes post-administration)