Mechanisms of Fasting Induced Reduction in Energy Expenditure (FIRE)

December 7, 2023 updated by: ETH Zurich

Mechanisms of Fasting Induced Reduction in Energy Expenditure - FIRE Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of energy expenditure (EE) determined by indirect calorimetry (kcal per 24h)
Time Frame: 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.
60 minutes after ingestion of test meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of free thyroxine
Time Frame: 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.
after 24 hours and after 12 hours of fasting
Level of free triiodothyronine
Time Frame: 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.
after 24 hours and after 12 hours of fasting
Respiratory quotient (RQ)
Time Frame: 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.
after 24 hours and after 12 hours of fasting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ETH Zurich

Collaborators

University Hospital, Basel, Switzerland

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 10, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EKNZ_2023-01401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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