Mechanisms of Fasting Induced Reduction in Energy Expenditure

NCT06134258 | Recruiting

• 1 other identifier: EKNZ_2023-01401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting

Keywords

Thermogenesis

Outcome Measures

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.

  60 minutes after ingestion of test meal

Secondary Outcomes (3)

• 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

Study Arms (2)

Fasting for 24 hours

OTHER

Fasting for 24 hours

Other: mixed meal test

Fasting for 12 hours

OTHER

Fasting for 12 hours

Other: mixed meal test

Interventions

mixed meal test OTHER

mixed meal test after fasting

Fasting for 12 hours; Fasting for 24 hours

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 to 40 years
• Body mass index 18.0 to 27.0 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• ETH Zurich: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, Switzerland

RECRUITING

Related Publications (7)

• 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.

  PMID: 33479452 BACKGROUND

• 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.

  PMID: 26499440 BACKGROUND

• 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.

  PMID: 26185280 BACKGROUND

• 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.

  PMID: 34194392 BACKGROUND

• 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.

  PMID: 29576535 BACKGROUND

• 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.

  PMID: 35470094 BACKGROUND

• 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.

  PMID: 34385400 BACKGROUND

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Matthias Betz

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Christian Wolfrum

  ETH Zurich

  STUDY CHAIR

Central Study Contacts

Matthias Betz

CONTACT

0041 61 265 2525; matthias.betz@usb.ch

Rahel Loeliger

CONTACT

0041 61 265 2525; Rahel.Loeliger@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, open label, cross-over, monocentric trial in healthy volunteers

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 18, 2023
• Study Start: November 15, 2023
• Primary Completion: April 18, 2026
• Study Completion: April 18, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)