Validation of Energy Expenditure Measures Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Leipzig
About this trial
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
This trial does not accept healthy volunteersQualifiers
Abilty to provide informed consent
Written declaration of consent
Healthy study participants
Able to perform moderate physical exercise using a bike ergometer
Disqualifiers
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
Trial population
Healthy, non-obese subjects of both sexes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
49 Participants
are grouped into 1 trial groupGroup A: Healthy
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.2
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.
Time frame
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
1
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)
Time frame
From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 11.2
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)
Time frame
From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.3
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)
Time frame
From enrollement to the end of 5th stay within the whole-room indirect calorimeter, study day 18.4
Body weight change
(Deviation from) near perfect energy balance relates to body weight change.
Time frame
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.Sponsors and contacts
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University of Leipzig
Lead sponsor
Helmholtz Zentrum München
Collaborator
University of Pisa
Collaborator
Source ClinicalTrials.gov