Physiological Reaction After Food Intake
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Electrocardiogram
研究概览
简要总结
The goal of this clinical trial is to clarify the normal response of the body after food intake.
Therefore, participants will wear three wearables for two weeks and document their food intake via an app- and picture-based protocol.
详细描述
The aim of this study is to investigate physiologically measurable reactions of the body to food intake. We want to find out which of the parameters collected can provide information about food intake and which techniques for data collection are expedient in this context. Ultimately, the aim is to develop a way of determining food intake from physiological data from physiological data without the user indicating this to the device.
The following data is collected continuously over a period of 2 weeks: Electrocardiogram (ECG), pulse rate from photoplethysmogram, body temperature, movement, skin conductance, and a continuous glucose measurement in the interstitium (CGM). The test subjects will also be asked to document each of their meals and snacks via an app using a photo. As an optional additional examination, female study participants will be offered an intravaginal temperature measurement. This independently performed measurement enables the core body temperature to be recorded.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5 - 25 kg/m2
排除标准
- •vegan diet
- •any kind of special diet, e.g. to lose weight
- •use of medication, except for thyroid hormones and contraceptives
结局指标
主要结局
Electrocardiogram
时间窗: 2 weeks
Changes in heart rate variability in response to food intake. Assessed through Vivalink ECG wearable that measures a continuous 3-channel ECG.
Body temperature
时间窗: 2 weeks
Changes in body temperature in response to food intake. Vivalink ECG and CORE sensor continuously measure the skin temperature. CORE sensor is also able to determine the body core temperature via a heat flux sensor. For women, body core temperature can be measured with the trackle wearable.
Skin conductance
时间窗: 2 weeks
Changes in skin conductance in response to food intake. CardioWatch wearable continuously measures the skin conductance
Glucose level
时间窗: 2 weeks
Changes in glucose levels in the interstitium in response to food intake. FreeStyle libre sensors continuously measure the glucose levels.
次要结局
- Physical Activity(2 weeks)
- Food intake(2 weeks)
研究者
Martin Heni
Prof. Dr. med. Martin Heni
University of Ulm