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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hospices Civils de Lyon.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00848471
First received: February 19, 2009
Last updated: August 18, 2009
Last verified: August 2009
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure at rest in standardized conditions [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

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
Experimental: 1
Quark RMR calorimeter (Cosmed)
 Device: Quark RMR
Quark RMR calorimeter (Cosmed)
Active Comparator: 2
Deltatrac II (GE health Care Clinical Systems)
 Device: Deltatrac II
Deltatrac II (GE health Care Clinical Systems)

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848471

Contacts
Contact: Secretary, Centre de Recherche en Nutrition Rhône Alpes 04.72.11.07.08 secretariat.crnh@chu-lyon.fr

Locations
France
Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot Recruiting
Lyon, Rhone-Alps, France, 69424
Sponsors and Collaborators
Hospices Civils de Lyon
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Investigators
Principal Investigator: Martine LAVILLE, M.D Hôpital Edouard Herriot
  More Information

No publications provided

Responsible Party: Pr Martine LAVILLE, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT00848471     History of Changes
Other Study ID Numbers: 2008.539
Study First Received: February 19, 2009
Last Updated: August 18, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Indirect calorimeter
Validation
Energy expenditure
Healthy volunteers

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013