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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Unknown

Conditions

Healthy
Obesity

Treatments

Device: Deltatrac II
Device: Quark RMR

Study type

Interventional

Funder types

Other

Identifiers

NCT00848471
2008.539

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Secretary, Centre de Recherche en Nutrition Rhône Alpes

Data sourced from clinicaltrials.gov

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