FIRE: Mechanisms of Fasting Induced Reduction in Energy Expenditure

Sponsor
ETH Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT06134258
Collaborator
University Hospital, Basel, Switzerland (Other)
40
1
2
13
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mixed meal test
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
randomized, open label, cross-over, monocentric trial in healthy volunteersrandomized, open label, cross-over, monocentric trial in healthy volunteers
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Mechanisms of Fasting Induced Reduction in Energy Expenditure - FIRE Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Fasting for 24 hours

Other: mixed meal test
mixed meal test after fasting

Other: Fasting for 8 hours

Other: mixed meal test
mixed meal test after fasting

Outcome Measures

Primary Outcome Measures

  1. change of energy expenditure (EE) determined by indirect calorimetry (kcal per 24h) [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.

Secondary Outcome Measures

  1. Level of free thyroxine [after 24 hours and after 12 hours of fasting]

    The thyroid hormone (TH) system is an important regulator of EE. We hypothesize that levels of TH are higher in the "spendthrift" than in the "thrifty" group.

  2. Level of free triiodothyronine [after 24 hours and after 12 hours of fasting]

    The thyroid hormone (TH) system is an important regulator of EE. We hypothesize that levels of TH are higher in the "spendthrift" than in the "thrifty" group.

  3. Respiratory quotient (RQ) [after 24 hours and after 12 hours of fasting]

    We hypothesize that the participants in the "thrifty" group have a lower proportion of fatty acid metabolism and therefore a higher RQ.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Basel Basel Switzerland

Sponsors and Collaborators

  • ETH Zurich
  • University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Matthias Betz, University Hospital, Basel, Switzerland
  • Study Chair: Christian Wolfrum, ETH Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ETH Zurich
ClinicalTrials.gov Identifier:
NCT06134258
Other Study ID Numbers:
  • EKNZ_2023-01401
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ETH Zurich

Study Results

No Results Posted as of Nov 18, 2023