HealthyProtocol QuarkNCT00848471
Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems)
A study testing Quark RMR and Deltatrac II in people with Healthy and Obesity, run by Hospices Civils de Lyon at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Quark RMR and Deltatrac II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Secretary, Centre de Recherche en Nutrition Rhône Alpes contact
France1 site, 1 recruiting
- Recruiting
Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot
Lyon, Rhone-Alps, 69424
About this study
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
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
Read the 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.
- Being tested
- Quark RMR, Deltatrac II
- Keywords
- Indirect calorimeter, Validation, Energy expenditure, Healthy volunteers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quark RMRDevice
Quark RMR calorimeter (Cosmed)
Deltatrac IIDevice
Deltatrac II (GE health Care Clinical Systems)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Quark RMR calorimeter (Cosmed) Receives: Device: Quark RMR |
| 2 | Active comparator | Deltatrac II (GE health Care Clinical Systems) Receives: Device: Deltatrac II |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure at rest in standardized conditions
Measured: At the end of the study
Secondary outcomes (1)
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
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Investigators
- Martine LAVILLE, M.D, Principal investigator, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848471
- Sponsor's protocol ID
- 2008.539
- Acronym
- Protocol Quark
- Status last verified
- Aug 2009
- First submitted
- 19 Feb 2009
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00848471
- Acronym / sponsor ID
- Protocol Quark / 2008.539
- Keywords
- Indirect calorimeter, Validation, Energy expenditure, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Quark RMRQuark RMR calorimeter (Cosmed) |
| 2 | Active comparator | Device: Deltatrac IIDeltatrac II (GE health Care Clinical Systems) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quark RMRQuark RMR calorimeter (Cosmed) | Device | 1 |
| Deltatrac IIDeltatrac II (GE health Care Clinical Systems) | Device | 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Secretary, Centre de Recherche en Nutrition Rhône Alpes contact
Martine LAVILLE, M.D principal investigator
Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quark RMR and Deltatrac II in people with Healthy and Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Secretary, Centre de Recherche en Nutrition Rhône Alpes (04.72.11.07.08, secretariat.crnh@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2009.