Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems)

Not Applicable

• Conditions: Healthy; Obesity
• Interventions: Device: Quark RMR; Device: Deltatrac II

• Registration Number: NCT00848471
• Lead Sponsor: Hospices Civils de Lyon

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-18
• Last Update Posted: 2009-08-19
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Quark RMR	Quark RMR calorimeter (Cosmed)
2	Deltatrac II	Deltatrac II (GE health Care Clinical Systems)

Primary Outcome Measures

Name	Time	Method
To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure at rest in standardized conditions	At the end of the study

Secondary Outcome Measures

Name	Time	Method
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	At the end of the study

Trial Locations

Locations (1)

Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot; 🇫🇷 Lyon, Rhone-Alps, France