Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Hospices Civils de Lyon Centre de Recherche en Nutrition Humaine Rhone-Alpe |
---|---|
Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00848471 |
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
Condition | Intervention |
---|---|
Healthy Obesity |
Device: Quark RMR Device: Deltatrac II |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Crossover Assignment |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Quark RMR calorimeter (Cosmed)
|
Device: Quark RMR
Quark RMR calorimeter (Cosmed)
|
2: Active Comparator
Deltatrac II (GE health Care Clinical Systems)
|
Device: Deltatrac II
Deltatrac II (GE health Care Clinical Systems)
|
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Secretary, Centre de Recherche en Nutrition Rhône Alpes | 04.72.11.07.08 | secretariat.crnh@chu-lyon.fr |
France, Rhone-Alps | |
Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot | Recruiting |
LYON, Rhone-Alps, France, 69424 |
Principal Investigator: | Martine LAVILLE, M.D | Hôpital Edouard Herriot |
Responsible Party: | Hôpital Edouard Herriot ( Pr Martine LAVILLE ) |
Study ID Numbers: | 2008.539 |
Study First Received: | February 19, 2009 |
Last Updated: | August 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00848471 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Indirect calorimeter Validation Energy expenditure Healthy volunteers |
Body Weight Signs and Symptoms Obesity Nutrition Disorders |
Overweight Overnutrition Healthy |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |