Clinical trial NCT00848471: Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems)
Official title: Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems) for Measuring Energy Expenditure at Rest and in Dynamic Phase After a Meal in Adult Healthy and Obese Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Obesity
Keywords: Indirect calorimeter
Validation
Energy expenditure
Healthy volunteers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Nutrition Humaine Rhone-Alpe
First posted: 2009-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark RMR versus Deltatrac II

Detailed description: Clinically, energy expenditure is usually estimated using predictive equations, such as the Harris-Benedict equation, which consider the patient's weight, height, age and sex to determine energy needs. However these have been shown to be unsystematically incorrect and may vary by 70-140% when compared with indirect and direct calorimetry measurements.

That is why the most popular method of measurement of energy expenditure in research is via indirect calorimetry using a metabolic cart. Indirect calorimetry is the measurement of the volume of oxygen consumption and carbon dioxide production.

Actually, there are few numbers of indirect calorimeters available commercialy. The Deltatrac II metabolic cart was the gold standard. It has been extensively used in clinical research both for resting metabolic rate and substrate oxidation measurement during postprandial or an insulin clamp. The Quark RMR is also a metabolic cart too which was launched on the market to compete with the others calorimeters measuring resting metabolic rate.

As the Quark RMR and Deltatrac II use the same measure device (paramagnetic analyser for oxygen detection, infrared absorption for carbon dioxide detection) with the same sensitivity and time response according to constructor's data, we want to compare these two calorimeters for the measurement of energy expenditure and substrate oxidation at rest and during a meal in standardized conditions.

Eligibility criteria: Inclusion Criteria:

* 18 to 60 years old
* BMI between 20 and 35 kg/m²
* Weight stable for at least 2 months
* Safety subject during medical consultation
* Normal TSH -CRP -glycemia - creatinin

Exclusion Criteria:

* Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflamatory diseases)
* Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)
* Eating disorder
* Intensive sportive activity (Baecke's score \>5)
* Subjects who Smoke
* Claustrophobic subjects
* Pregnant women

Primary outcomes:
measure: To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure at rest in standardized conditions
timeFrame: At the end of the study
Secondary outcomes:
measure: To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure after a food intake of 600kcal
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot
state: Rhone-Alps
Study officials:
affiliation: Hôpital Edouard Herriot
name: Martine LAVILLE, M.D
role: PRINCIPAL_INVESTIGATOR
References: