Obesity PreventionValEENCT07155564
Validation of Energy Expenditure Measures Study
An observational study of Obesity Prevention and Healthy, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity Prevention, Healthy
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- 26 Aug 2025to 31 Jan 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy, non-obese subjects of both sexes.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haiko Schlögl, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Clinic for Endocrinology, Nephrology and Rheumatology, University of Leipzig
Leipzig, Saxony, 04103
Sascha Heinitz, MD, +49 341 9713389, sascha.heinitz@medizin.uni-leipzig.de
Haiko Schlögl, MD, +49 341 9713389, sascha.heinitz@medizin.uni-leipzig.de
About this study
Official title: Energy Balance Within a Whole-Room Indirect Calorimeter and Its Relevance for Energy Expenditure Measures
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.
Read more
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:
- 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.
- 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.
- To investigate whether differences in energy expenditure during energy balance during moderate and strenuous physical activity influence food intake.
- To investigate whether energy intake in relation to energy expenditure during energy balance is related to weight development
Read the detailed description
Technical Validation: Six 24-hour methanol burns within each of the two WRICs will be conducted for technical validation.
Biological Validation and Energy Balance Component:
After providing informed consent and meeting inclusion/exclusion criteria, study participants will follow a weight-maintaining diet before their first 24-hour stay in a WRIC (Day 4). During this stay, energy expenditure will be measured under conditions of estimated energy balance. As a measure of energy expnediture relative to energy intake, energy balance will be estimated based on resting energy expenditure, an estimated physical activity level, and an approximation formula applied during the screening procedure.
A second 24-hour stay in the WRIC (Day 6), also under conditions of estimated energy balance, will serve for biological validation. After following the weight-maintaining diet for three additional days, a third 24-hour WRIC stay (Day 10) will assess the achievement of near-perfect energy balance. On the day following this stay (Day 11), participants will have access to a buffet and will be allowed to eat ad libitum.
Subsequently, a 3-day run-in period under weight-maintenance conditions will precede reassessment of 24-hour energy expenditure during increased physical activity in the WRIC (Days 15 and 17). Energy expenditure during energy balance will again be compared to ad libitum food intake at a buffet (Day 18).
Follow-up weight measurements will be conducted one year after study completion to evaluate the influence of achieving near-perfect energy balance-or deviations from it-on weight change. Additionally, fasting blood samples will be collected before and after each WRIC stay, as well as before and after ad libitum food intake, to measure hormones related to appetite control and satiety.
Sample size was calculated assuming a detectable mean difference in energy balance of 100 kcal, a standard deviation of 200 kcal, a two-sided α=0.05, and statistical power ≥80%, resulting in an analytical target sample size of 34 study completers. To account for an anticipated dropout rate of approximately 30%, 49 participants will be enrolled. However, interim analysis after n = 8 subjects will be conducted to adjust needed sample size to variability as detected using here implied methods of indirect calorimetry.
The statistical evaluation with regard to i) technical validation, ii) biological validation, and iii) testing the achievability of an energy balance and its effect on energy consumption are carried out using parametric and non-parametric tests. Data are given as mean value with standard deviation. The significance level is P < 0.05.
- Conditions
- Obesity Prevention, Healthy
- Keywords
- Energy balance, Energy expenditure, Weight change, Energy intake, Indirect calorimetry
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy subjects of both sexes meeting inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy balance derived from diet-prescribed energy intake and whole-room indirect calorimeter-measured 24-hour energy expenditure
Energy balance is calculated as diet-prescribed energy intake minus 24-hour energy expenditure measured by whole-room indirect calorimetry. Energy expenditure and energy intake are assessed repeatedly under low- and high-energy-turnover conditions. The primary analysis compares energy balance during the diet-specified weight-maintaining diet condition with energy balance after adjustment of energy intake to WRIC-measured 24-hour energy expenditure.
Measured: 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.
Measured: 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
Compared to common approximation formulas, achieving near perfect energy balance using a WRIC has an influence on energy expenditure measures (i.e. 24-hour energy expenditure, sleeping energy expenditure, diet-induced thermogenesis/awake-and-fed thermogenesis, physical exercise energy expenditure)
Measured: From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 11.
Physical exercise expenditure
Compared to common approximation formulas, achieving near perfect energy balance using a WRIC has an influence on energy expenditure measures in the setting of increased physical activity (i.e. 24-hour energy expenditure, sleeping energy expenditure, diet-induced thermogenesis/awake-and-fed thermogenesis, physical exercise energy expenditure)
Measured: From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.
Concentrations of hormones involved in energy intake
(Deviation from) near perfect energy balance relates to ad libitum energy intake and changes in hormones implied in appetite control/satiety. Outcome measures: ad libitum food intake during buffet, Leptin, Ghrelin, thyroid hormones, Cortisol, Insulin, IGF-1, Adiponectin, FGF21)
Measured: From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.
Body weight change
(Deviation from) near perfect energy balance relates to body weight change.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start26 Aug 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Helmholtz Zentrum München, University of Pisa
- Responsible party
- Principal investigator, Sascha Heinitz, University of Leipzig
- Investigators
- Sascha Heinitz, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155564
- Sponsor's protocol ID
- 121-24/ek
- Acronym
- ValEE
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision not to share IPD is based on considerations of participant privacy and data protection. Although all data are anonymized, the sensitive nature of the information collected in this study necessitates careful handling to minimize any risk of identification. Furthermore, the informed consent provided by participants does not explicitly include provisions for data sharing beyond the current study. To ensure compliance with ethical guidelines and data protection regulations, the study team has decided not to make IPD available publicly or to external researchers. However, summary data and study findings will be shared through peer-reviewed publications, ensuring transparency and the opportunity for scientific discourse.
Publications
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.
PubMed 35920141Piaggi 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.
PubMed 23974925Weyer 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.
PubMed 10454105Hollstein 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.
PubMed 31172178Reinhardt 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.
PubMed 25964395Heinitz 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.
PubMed 32599082Ravussin 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.
PubMed 3782471Venti 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.
PubMed 19923376Weise 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.
PubMed 23736368Basolo 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.
PubMed 29305947Hall 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.
PubMed 22434603