Identifying Physiological Biomarkers for Monitoring Dietary Behaviours
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes of blood pressure associated with dietary events (pre- vs post- meal).
研究概览
简要总结
Background: Measuring what people eat is a challenge in nutrition research. Traditional methods, like food diaries, rely on self-reporting of individuals, and suffer from poor accuracy and recall bias.
Aims: This project aims to identify physiological biomarkers related to food and energy intake, which may be used to develop an objective tool to estimate individuals' food intake in future. Eating behaviours are accompanied by significant physiological changes such as skin temperature, blood oxygen saturation, pulse rate etc. The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour, such as meal size, eating speed, and duration of meals.
Study design: Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility. Each visit will last for approximately 2 hr. They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order. During eating events, the investigators will track their physiological changes via a bedside monitor and wearable sensors. Blood samples will be taken from participants to measure their glycaemic response. Associations between energy load, glycaemic response, and physiological changes will be investigated. Our findings may promote an accelerated development of a wearable tool for dietary assessment in future.
详细描述
1 Participants
10 healthy male and female participants. This is a pilot study in a new area and therefore a formal power calculation is not possible.
- Recruitment
Participants will be recruited from existing healthy volunteer databases and by advertisement in public places. Adverts may be placed in newspapers and put up in public buildings. A contact number on the advert will enable potential participants to contact the research team at Imperial College London. Participation in the study will be entirely voluntary. No undue influence will be exerted by the researchers. Participants will be free to withdraw from the study at any time.
3 Pre-Screening Questionnaire
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Age between 18-65 years (inclusive)
- •Body mass index (BMI) of 18-30 kg/m2
- •Willingness and ability to give written informed consent.
- •Willingness and ability to understand, to participate and to comply with the study requirements
排除标准
- •Outside of specified age and BMI range
- •Chronic medical conditions including for eating disorders, diabetes, obesity, hypertension, cancer, acute infectious disease, renal disease, cardiovascular disease, and chronic gastrointestinal condition.
- •Taking part in another research study or donating any blood in the last 3 months
结局指标
主要结局
Changes of blood pressure associated with dietary events (pre- vs post- meal).
时间窗: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Systolic and diastolic blood pressure in mmHg before, during and after the dietary event
Changes of skin temperature associated with dietary events (pre- vs post- meal).
时间窗: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Skin temperature in celsius before, during and after the dietary event
Changes of oxygen saturation associated with dietary events (pre- vs post- meal).
时间窗: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Oxygen saturation in % before, during and after the dietary event
Changes of heart rate associated with dietary events (pre- vs post- meal).
时间窗: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Heart rate in bpm before, during and after the dietary event
Changes of hand movements associated with dietary events (pre- vs post- meal).
时间窗: Starting 5 minutes before the meal and lasting for 60 minutes postprandially.
Hand movements recorded in sensors before, during and after the dietary event
次要结局
- Vital signs associated with blood glucose, insulin and hormonal levels(Starting 5 minutes before the meal and lasting for 60 minutes postprandially.)
- Changes of heart oxygen saturation associated with energy intake (high vs. low calorie meals)(Starting 5 minutes before the meal and lasting for 60 minutes postprandially.)
- Changes of heart rate associated with energy intake (high vs. low calorie meals)(Starting 5 minutes before the meal and lasting for 60 minutes postprandially.)
- Changes of blood pressure associated with energy intake (high vs. low calorie meals)(Starting 5 minutes before the meal and lasting for 60 minutes postprandially.)
- Changes of skin temperature associated with energy intake (high vs. low calorie meals)(Starting 5 minutes before the meal and lasting for 60 minutes postprandially.)
- Changes of hand movements associated with energy intake (high vs. low calorie meals)(Starting 5 minutes before the meal and lasting for 60 minutes postprandially.)