Status:
RECRUITING
Validation of Energy Expenditure Measures Study
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Helmholtz Center Munich
University of Pisa
Conditions:
Obesity Prevention
Healthy
Eligibility:
All Genders
18-40 years
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 a...
Detailed Description
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 inform...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT07155564
Start Date
August 26 2025
End Date
January 31 2029
Last Update
January 6 2026
Active Locations (1)
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1
Department of Internal Medicine, Clinic for Endocrinology, Nephrology and Rheumatology, University of Leipzig
Leipzig, Saxony, Germany, 04103