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RecruitingNCT06134258FIREUpdated May 30, 2025

Mechanisms of Fasting Induced Reduction in Energy Expenditure

An interventional study of mixed meal test in Fasting, sponsored by ETH Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by ETH Zurich · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Fasting

Keywords

  • Thermogenesis
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Fasting for 24 hours

    Fasting for 24 hours

    Other: mixed meal test

  • Other
    Fasting for 12 hours

    Fasting for 12 hours

    Other: mixed meal test

Interventions

  • Othermixed meal test

    mixed meal test after fasting

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: 60 minutes after ingestion of test meal

Secondary outcomes

  1. Level of free thyroxine

    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.

    Time frame: after 24 hours and after 12 hours of fasting

  2. Level of free triiodothyronine

    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.

    Time frame: after 24 hours and after 12 hours of fasting

  3. Respiratory quotient (RQ)

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

    Time frame: after 24 hours and after 12 hours of fasting

06

Study locations

1 of 1 sites recruiting
  • University Hospital Basel
    Basel, Switzerland
    Recruiting
07

References and documents

Publications

  • Hollstein T, Heinitz S, Basolo A, Krakoff J, Votruba SB, Piaggi P. Reduced metabolic efficiency in sedentary eucaloric conditions predicts greater weight regain in adults with obesity following sustained weight loss. Int J Obes (Lond). 2021 Apr;45(4):840-849. doi: 10.1038/s41366-021-00748-y. Epub 2021 Jan 21. PubMed 33479452 ↗
  • Reinhardt M, Schlogl M, Bonfiglio S, Votruba SB, Krakoff J, Thearle MS. Lower core body temperature and greater body fat are components of a human thrifty phenotype. Int J Obes (Lond). 2016 May;40(5):754-60. doi: 10.1038/ijo.2015.229. Epub 2015 Oct 26. PubMed 26499440 ↗
  • Schlogl M, Piaggi P, Pannacciuli N, Bonfiglio SM, Krakoff J, Thearle MS. Energy Expenditure Responses to Fasting and Overfeeding Identify Phenotypes Associated With Weight Change. Diabetes. 2015 Nov;64(11):3680-9. doi: 10.2337/db15-0382. Epub 2015 Jul 16. PubMed 26185280 ↗
  • Maushart CI, Senn JR, Loeliger RC, Kraenzlin ME, Muller J, Becker AS, Balaz M, Wolfrum C, Burger IA, Betz MJ. Free Thyroxine Levels are Associated with Cold Induced Thermogenesis in Healthy Euthyroid Individuals. Front Endocrinol (Lausanne). 2021 Jun 14;12:666595. doi: 10.3389/fendo.2021.666595. eCollection 2021. PubMed 34194392 ↗
  • Redman LM, Smith SR, Burton JH, Martin CK, Il'yasova D, Ravussin E. Metabolic Slowing and Reduced Oxidative Damage with Sustained Caloric Restriction Support the Rate of Living and Oxidative Damage Theories of Aging. Cell Metab. 2018 Apr 3;27(4):805-815.e4. doi: 10.1016/j.cmet.2018.02.019. Epub 2018 Mar 22. PubMed 29576535 ↗
  • Oeckl J, Janovska P, Adamcova K, Bardova K, Brunner S, Dieckmann S, Ecker J, Fromme T, Funda J, Gantert T, Giansanti P, Hidrobo MS, Kuda O, Kuster B, Li Y, Pohl R, Schmitt S, Schweizer S, Zischka H, Zouhar P, Kopecky J, Klingenspor M. Loss of UCP1 function augments recruitment of futile lipid cycling for thermogenesis in murine brown fat. Mol Metab. 2022 Jul;61:101499. doi: 10.1016/j.molmet.2022.101499. Epub 2022 Apr 22. PubMed 35470094 ↗
  • Pontzer H, Yamada Y, Sagayama H, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Bovet P, Buchowski MS, Butte NF, Camps SG, Close GL, Cooper JA, Cooper R, Das SK, Dugas LR, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, Kraus WE, Kushner RF, Lambert EV, Leonard WR, Lessan N, Martin C, Medin AC, Meijer EP, Morehen JC, Morton JP, Neuhouser ML, Nicklas TA, Ojiambo RM, Pietilainen KH, Pitsiladis YP, Plange-Rhule J, Plasqui G, Prentice RL, Rabinovich RA, Racette SB, Raichlen DA, Ravussin E, Reynolds RM, Roberts SB, Schuit AJ, Sjodin AM, Stice E, Urlacher SS, Valenti G, Van Etten LM, Van Mil EA, Wells JCK, Wilson G, Wood BM, Yanovski J, Yoshida T, Zhang X, Murphy-Alford AJ, Loechl C, Luke AH, Rood J, Schoeller DA, Westerterp KR, Wong WW, Speakman JR; IAEA DLW Database Consortium. Daily energy expenditure through the human life course. Science. 2021 Aug 13;373(6556):808-812. doi: 10.1126/science.abe5017. PubMed 34385400 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06134258
Lead sponsor
ETH Zurich
Collaborators
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Nov 15, 2023
Primary completion
Apr 18, 2026 (estimated)
Completion
Apr 18, 2026 (estimated)
Last update
May 30, 2025

Study contacts

Matthias Betz
Contact
matthias.betz@usb.ch
0041 61 265 2525
Rahel Loeliger
Contact
Rahel.Loeliger@usb.ch
0041 61 265 2525
Matthias Betz
principal investigator · University Hospital, Basel, Switzerland
Christian Wolfrum
study chair · ETH Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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