Validation of Energy Expenditure Measures Study

NCT07155564 | Recruiting

• 1 other identifier: 121-24/ek
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The energy that the human body burns and the amount of food consumed determine a person's body weight. If food intake covers the amount of energy burned, body weight remains constant - a state known as energy balance. Achieving an energy balance is not easy in everyday life. This is reflected in the increasing number of people suffering from morbid obesity. To counteract this development, it is important to have a better understanding of how much food a person should eat. In this study, the investigators will investigate the amount of food needed to meet a person's energy needs and bring them into energy balance. Primary aims of the study are i) to technically and biologically validate two whole-room indirect calorimeters (WRICs) and ii) by using whole-room indirect calorimetry, to achieve a more accurate estimate of a person's emergy balance compared to common approximation formulas. Secondary study aims:

1. 1.To investigate whether the transfer of a person into energy balance using WRIC has an influence on energy expenditure measures compared to the transfer into energy balance using the usual approximation formula.
2. 2.To investigate whether the transfer of a person into energy balance using WRIC has an influence on activity-dependent energy expenditure measures compared to the transfer into energy balance using the usual approximation formula.
3. 3.To investigate whether differences in energy expenditure during energy balance during moderate and strenuous physical activity influence food intake.
4. 4.To investigate whether energy intake in relation to energy expenditure during energy balance is related to weight development

Conditions

Obesity Prevention; Healthy

Keywords

Energy balance; Energy expenditure; Weight change; Energy intake; Indirect calorimetry

Outcome Measures

Primary Outcomes (3)

• Energy expenditure

  Repeated assessment of energy expenditure in the setting of a whole-room indirect calorimeter and relative to prior energy expenditure assessment using the ventilated hood method (canopy) and estimation formula.

  From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.

• Energy intake

  Repeated assessment of energy intake in the setting of a whole-room indirect calorimeter and relative to prior energy expenditure assessment using the ventilated hood method (canopy) and estimation formula.

  From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.

• Coefficient of variation

  Technical and biological validation via repeated assessment of methanol combustion as well as repeated stays within the whole-room indirect calorimeters. Measures: recovery, accuracy, macronutrient oxidation rates, respiratory exchange ratio, energy expenditure measures.

  Prior to enrollement of subjects (technical validation). From enrollement to the end of second stay within the whole-room indirect calorimeter, study day 7.

Secondary Outcomes (4)

• Energy expenditure

  From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 11.

• Physical exercise expenditure

  From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.

• Concentrations of hormones involved in energy intake

  From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.

• Body weight change

  From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18. Body weight change follow-up one year after completion of the study.

Study Arms (1)

Healthy

Healthy subjects of both sexes meeting inclusion criteria.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Cisgender subjects
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, non-obese subjects of both sexes.

You may qualify if:

• Abilty to provide informed consent
• Written declaration of consent
• Healthy study participants
• Able to perform moderate physical exercise using a bike ergometer
• Women: continuous contraception/fullicular phase of menstrual cycle

You may not qualify if:

• Weight change \> 5 kg or 5% of body weight in the last 3 months
• Nicotine abuse, Alcohol/drug abuse
• Strenuous physical activity in everyday life \> 1 h per day
• Body mass index \< 18.5 kg/m² or ≥ 40 kg/m²
• Chronic diseases with an impact on energy expenditure
• Food allergy/intolerance, vegan diet
• Circumstances that speak against the application of wearable accelerometers (e.g. silicone contact allergy)
• Impaired fasting glucose, diabetes mellitus and prediabetes
• Pregnancy/breastfeeding
• Claustrophobia
• Refusal to communicate incidental findings

Sponsors & Collaborators

• University of Leipzig: lead
• Helmholtz Center Munich: collaborator
• University of Pisa: collaborator

Study Sites (1)

Department of Internal Medicine, Clinic for Endocrinology, Nephrology and Rheumatology, University of Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (11)

• Stinson EJ, Rodzevik T, Krakoff J, Piaggi P, Chang DC. Energy expenditure measurements are reproducible in different whole-room indirect calorimeters in humans. Obesity (Silver Spring). 2022 Sep;30(9):1766-1777. doi: 10.1002/oby.23476. Epub 2022 Aug 3.

  PMID: 35920141 BACKGROUND

• Piaggi P, Krakoff J, Bogardus C, Thearle MS. Lower "awake and fed thermogenesis" predicts future weight gain in subjects with abdominal adiposity. Diabetes. 2013 Dec;62(12):4043-51. doi: 10.2337/db13-0785. Epub 2013 Aug 23.

  PMID: 23974925 BACKGROUND

• Weyer C, Snitker S, Rising R, Bogardus C, Ravussin E. Determinants of energy expenditure and fuel utilization in man: effects of body composition, age, sex, ethnicity and glucose tolerance in 916 subjects. Int J Obes Relat Metab Disord. 1999 Jul;23(7):715-22. doi: 10.1038/sj.ijo.0800910.

  PMID: 10454105 BACKGROUND

• Hollstein T, Ando T, Basolo A, Krakoff J, Votruba SB, Piaggi P. Metabolic response to fasting predicts weight gain during low-protein overfeeding in lean men: further evidence for spendthrift and thrifty metabolic phenotypes. Am J Clin Nutr. 2019 Sep 1;110(3):593-604. doi: 10.1093/ajcn/nqz062.

  PMID: 31172178 BACKGROUND

• Reinhardt M, Thearle MS, Ibrahim M, Hohenadel MG, Bogardus C, Krakoff J, Votruba SB. A Human Thrifty Phenotype Associated With Less Weight Loss During Caloric Restriction. Diabetes. 2015 Aug;64(8):2859-67. doi: 10.2337/db14-1881. Epub 2015 May 11.

  PMID: 25964395 BACKGROUND

• Heinitz S, Hollstein T, Ando T, Walter M, Basolo A, Krakoff J, Votruba SB, Piaggi P. Early adaptive thermogenesis is a determinant of weight loss after six weeks of caloric restriction in overweight subjects. Metabolism. 2020 Sep;110:154303. doi: 10.1016/j.metabol.2020.154303. Epub 2020 Jun 27.

  PMID: 32599082 BACKGROUND

• Ravussin E, Lillioja S, Anderson TE, Christin L, Bogardus C. Determinants of 24-hour energy expenditure in man. Methods and results using a respiratory chamber. J Clin Invest. 1986 Dec;78(6):1568-78. doi: 10.1172/JCI112749.

  PMID: 3782471 BACKGROUND

• Venti CA, Votruba SB, Franks PW, Krakoff J, Salbe AD. Reproducibility of ad libitum energy intake with the use of a computerized vending machine system. Am J Clin Nutr. 2010 Feb;91(2):343-8. doi: 10.3945/ajcn.2009.28315. Epub 2009 Nov 18.

  PMID: 19923376 BACKGROUND

• Weise CM, Hohenadel MG, Krakoff J, Votruba SB. Body composition and energy expenditure predict ad-libitum food and macronutrient intake in humans. Int J Obes (Lond). 2014 Feb;38(2):243-51. doi: 10.1038/ijo.2013.85. Epub 2013 May 23.

  PMID: 23736368 BACKGROUND

• Basolo A, Votruba SB, Heinitz S, Krakoff J, Piaggi P. Deviations in energy sensing predict long-term weight change in overweight Native Americans. Metabolism. 2018 May;82:65-71. doi: 10.1016/j.metabol.2017.12.013. Epub 2018 Jan 3.

  PMID: 29305947 BACKGROUND

• Hall KD, Heymsfield SB, Kemnitz JW, Klein S, Schoeller DA, Speakman JR. Energy balance and its components: implications for body weight regulation. Am J Clin Nutr. 2012 Apr;95(4):989-94. doi: 10.3945/ajcn.112.036350. No abstract available. Erratum In: Am J Clin Nutr. 2012 Aug;96(2):448.

  PMID: 22434603 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sascha Heinitz, MD

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha Heinitz, MD

CONTACT

+49 341 97 13389; sascha.heinitz@medizin.uni-leipzig.de

Haiko Schlögl, MD

CONTACT

+49 341 97 13389

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: September 4, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)