Clinical trial NCT06134258: Mechanisms of Fasting Induced Reduction in Energy Expenditure
Official title: Mechanisms of Fasting Induced Reduction in Energy Expenditure - FIRE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fasting
Keywords: Thermogenesis
Lead sponsor: ETH Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, open label, cross-over, monocentric trial in healthy volunteers
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age: 18 to 40 years
* Body mass index 18.0 to 27.0 kg/m²
* Exclusion Criteria:
* 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

Primary outcomes:
measure: change of energy expenditure (EE) determined by indirect calorimetry (kcal per 24h)
timeFrame: 60 minutes after ingestion of test meal
Secondary outcomes:
measure: Level of free thyroxine
timeFrame: after 24 hours and after 12 hours of fasting
measure: Level of free triiodothyronine
timeFrame: after 24 hours and after 12 hours of fasting
measure: Respiratory quotient (RQ)
timeFrame: after 24 hours and after 12 hours of fasting
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias Betz
role: PRINCIPAL_INVESTIGATOR
affiliation: ETH Zurich
name: Christian Wolfrum
role: STUDY_CHAIR
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