Clinical trial

Validation of Energy Expenditure Measures Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT07155564

Recruiting nowNot applicableObservational

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity Prevention, Healthy

Full registry 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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

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

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.

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

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.

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

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Internal Medicine, Clinic for Endocrinology, Nephrology and Rheumatology, University of Leipzig🇩🇪 Leipzig, Saxony, Germany

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Sascha Heinitz, MDContact

Email · Call +49 341 9713389

Haiko Schlögl, MDContact

Email · Call +49 341 9713389

Sascha Heinitz, MDPrincipal Investigator