NCT07155564 Validation of Energy Expenditure Measures Study
| NCT ID | NCT07155564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leipzig |
| Condition | Obesity Prevention |
| Study Type | OBSERVATIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 34 participants in total. It began in 2025-08-26 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Sascha Heinitz, MD
PRINCIPAL INVESTIGATOR
University of Leipzig
Frequently Asked Questions
Who can join the NCT07155564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Obesity Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07155564 currently recruiting?
Yes, NCT07155564 is actively recruiting participants. Contact the research team at sascha.heinitz@medizin.uni-leipzig.de for enrollment information.
Where is the NCT07155564 trial being conducted?
This trial is being conducted at Leipzig, Germany.
Who is sponsoring the NCT07155564 clinical trial?
NCT07155564 is sponsored by University of Leipzig. The principal investigator is Sascha Heinitz, MD at University of Leipzig. The trial plans to enroll 34 participants.
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