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

Healthy Clinical Trial

— Protocol Quark  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00848471
• Other study ID #: 2008.539
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2009
• Last updated: August 18, 2009
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: Hospices Civils de Lyon
• Contact: Secretary, Centre de Recherche en Nutrition Rhône Alpes
• Phone: 04.72.11.07.08
• Email: secretariat.crnh[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy
• Obesity

Intervention

Device:
• Quark RMR
Quark RMR calorimeter (Cosmed)
• Deltatrac II
Deltatrac II (GE health Care Clinical Systems)

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot	Lyon	Rhone-Alps

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Centre de Recherche en Nutrition Humaine Rhone-Alpe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No