Loading clinical trials...
Loading clinical trials...
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. 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. 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. 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. To investigate whether differences in energy expenditure during energy balance during moderate and strenuous physical activity influence food intake. 4. To investigate whether energy intake in relation to energy expenditure during energy balance is related to weight development
Technical Validation: Eight 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. N = 34 subjects are required to detect a statistically significant difference in energy balance after measuring energy expenditure using a WRIC. 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.
Age
18 - 40 years
Sex
ALL
Healthy Volunteers
No
Department of Internal Medicine, Clinic for Endocrinology, Nephrology and Rheumatology, University of Leipzig
Leipzig, Saxony, Germany
Start Date
August 26, 2025
Primary Completion Date
January 31, 2029
Completion Date
January 31, 2029
Last Updated
January 6, 2026
34
ESTIMATED participants
Lead Sponsor
University of Leipzig
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00090662