Mechanisms of Fasting Induced Reduction in Energy Expenditure - FIRE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change of energy expenditure (EE) determined by indirect calorimetry (kcal per 24h)
研究概览
简要总结
Fasting reduces the energy consumption of the human body. The extent of this adaptation varies significantly between different individuals. The aim of this research project is to investigate how this adaptation of the metabolism is regulated by the body. For this purpose, we will first measure how the so-called basal metabolic rate of the body reacts to a short-term fasting of 24 h in a preliminary study. Those subjects with a particularly pronounced and those subjects with an only slightly pronounced reaction of the basal metabolic rate will be invited to the main study.
Here, in random order (24 h fasting vs. 8 h fasting), the following is compared
- how the basal metabolic rate of the body reacts to the reduced energy intake.
- how the energy metabolism increases after a test meal
- what role in particular the thyroid hormones play in this adaptation. In addition, a sample of the subcutaneous adipose tissue is taken in each case and it is examined how the regulation of metabolic processes at the cellular level.
详细描述
The extent of this adaptation varies significantly between different individuals. The aim of this research project is to investigate how this adaptation of the metabolism is regulated by the body. For this purpose, we will first measure how the so-called basal metabolic rate of the body reacts to a short-term fasting of 24 h in a preliminary study. Those subjects with a particularly pronounced and those subjects with an only slightly pronounced reaction of the basal metabolic rate will be invited to the main study.
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
- •Age: 18 to 40 years
- •Body mass index 18.0 to 27.0 kg/m²
排除标准
- •Chronic conditions necessitating medical treatment (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
- •Known or suspected non-compliance, drug or alcohol abuse,
- •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,
- •Hypothyroidism or hyperthyroidism
- •Pregnant, breastfeeding and menopausal women
结局指标
主要结局
change of energy expenditure (EE) determined by indirect calorimetry (kcal per 24h)
时间窗: 60 minutes after ingestion of test meal
Difference of EE (determined by indirect calorimetry) between baseline and 60 minutes after ingestion of the liquid test meal. Both measurements will be performed after an overnight fasting period.
次要结局
- Level of free thyroxine(after 24 hours and after 12 hours of fasting)
- Level of free triiodothyronine(after 24 hours and after 12 hours of fasting)
- Respiratory quotient (RQ)(after 24 hours and after 12 hours of fasting)