Computer SimulationModelheartNCT01209572
Modelling of Energy Expenditure From Heart Rate, Accelerometry and Other Physiological Parameters
A study testing calorimetric chamber and Free living conditions in people with Computer Simulation and Energy Expenditure, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
Trial summary
At this time, 24h energy expenditure is rarely assessed under free-living conditions for specific individuals because of the lack of cheap and accurate software/materials to record the energy expenditure. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer Simulation, Energy Expenditure, Energy Metabolism
- What is being tested?
- calorimetric chamber and Free living conditions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Sep 2010
- 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
- men and women
- age: 18-60 years
- BMI between 19 and 25 kg/m²
- subject considered as healthy after clinical examination and medical questionnaire
- subject giving his/her written informed consent
- subject willing to comply with study procedures
- affiliated to National Health Insurance
Who cannot join
- biological results judged abnormal by investigator
- positive serologies to HIV or HCV
- respiratory failure or cardiovascular problem
- taking medicine : beta blockers, corticoids, anti-inflammatory drug, thyroid hormones, insulin
- abnormal ECG
- more than 10% of weight or gain loss in the three last months
Show all 17Show fewer
- tumoral, inflammatory, pulmonary, renal, digestive or liver diseases
- surgery made less than 6 months before the study beginning
- thyroid disease
- pregnant women and nursing mother
- insanity
- smoker
- claustrophobic
- no affiliated to national health insurance people
- refusal to sign informed consent
- refusal to be registered on the national volunteers data file
- currently participating or who having got 4500€ in this year before to have participated in another clinical trial
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, Auvergne, 63009
About this study
Official title: Modelling of 24h Energy Expenditure From Heart Rate, Actimetry and Other Parameters Recorded Under Free-living Conditions
At this time, 24h energy expenditure is rarely assessed under free-living conditions for specific individuals because of the lack of cheap and accurate software/materials to record the energy expenditure. Some affordable and convenient tools (Polar heart rate monitor, Actiheart, SenseWear Armband) are available on the market but the predictive equations comprised into the software provided with these tools generally miscalculate the energy expenditure (by about +/-10%). Because of this deficiency, the investigators have a poor knowledge of the modification of the energy expended during daily life activities and over 24h in subjects belonging to groups of various ages and physiological states. The investigators hypothesise that it could be possible to improve the energy expenditure prediction.
The project aims at providing a mathematical model (equations) that predicts energy expenditure with an error near to 5%. Two groups of 60 sedentary to athletic normal weight volunteers aged between 18-60 years participate to this study. The first group stay for 26h in calorimetric chambers. During this stay energy expenditure ,heart rate, accelerometry, and other parameters are recorded during various activities. These data will serve to construct the model. The same type of recordings are performed on second group of volunteers in free living conditions. Their energy expenditure is measured overall by doubly labeled water. The data of the second group will serve to validate the model. The error percentage of the model is defined by the ratio of the value of the difference between prediction and reference measure to the reference measure. Concordance between predictions and measures will be evaluated by Bland - Altman plots.
Read the detailed description
All the volunteers have a visit of inclusion in the Centre de Recherche en Nutrition Humaine. During this visit, the volunteers are informed of the methods of the protocol, the taking of samples, the disadvantages and constraints, on the basis of information letter. They have a medical interrogation and a complete clinical examination by an investigatory doctor or Co-investigator. The biological assessment is requiring 10 ml of blood and including: the analysis of the TSH, a blood count, a sedimentation test. Moreover, for the women in age to procreate, the analysis of the beta - HCG is made. To take another blood sample (10 ml) is necessary for the realization of serology HIV/HCV in the volunteers of the group of doubly labeled water, who provide samples of urine and saliva. The results are communicated to the volunteers confidentially.
Following the visit of inclusion and the signature of the consent form, a food consumption survey is performed to evaluate the energy intakes of the volunteers. Moreover, the body composition and the level of physical-activity of the volunteers are evaluated by biphotonic absorptiometry (DEXA) and using questionnaire MAQ (Modifiable Activity Questionnaire, translated and adapted by Vuillemin and Al, 1999), respectively.
The volunteers of the first group (60) performed a maximal aerobic power test on ergocycle to evaluate their maximum aerobic physical capacity (VO2max), in a hospital laboratory. A measurement of the body composition by biphotonic absorptiometry is also carried out to determine their lean and fat mass. Then, the volunteers stay 26 hours in calorimetric rooms (one evening, one night and a day). The data of indirect calorimetry (O2 consumption and production of CO2), heart rate , actimetry and other parameters are taken into account as from midnight. After one night of sleep, the individuals have to carry out series of state or exercises simulating the daily physical-activities (sleeping, writing 15 min, standing-sitting 5 min, standing 15 min, strolling 15 min, rest 20 min, eating 20 min, household 20 min, stepper 20 min, walking on treadmill at increasing speed 3 km/h, 4 km/h, 5 km/h and 6 km/h during 20 minutes). The volunteers have also to answer questionnaires on their perception of hunger, their emotional state and their visual appreciation of 6 food products at 5 times of the day (before and after the breakfast, before and after the lunch and about 16:30 pm). The rest of the time, their activities are free (watching TV, reading, listening radio …). Measurements finish towards 18:00 and volunteers go home. The meals are balanced in proteins/glucides/lipids and cover energy needs. The menus are established by the dieticians. The meals in calorimetric room are prepared in double weighing to make it possible to calculate the actual quantities.
The second group of volunteers (60) follow the protocol of doubly labeled water to evaluate their energy expenditure during 10 days in free living conditions. For this period, their heart rate, parameters of actimetry and other parameters are recorded . The participants of this second group also answer the questionnaires of perception of hunger, emotional state and visual appreciation of 6 food products, over one day at home. The physical data recorded on this second group will be introduced into the predictive equations. The estimated energy expenditure will be compared with the energy expenditure measured by the technique of doubly labeled water. The answers to the questionnaires filled out by the volunteers of the two groups will be also compared.
- Conditions
- Computer Simulation, Energy Expenditure, Energy Metabolism
- Being tested
- calorimetric chamber, Free living conditions
- Keywords
- energy expenditure, heart rate, accelerometry, body temperature, heat flow galvanic response of skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calorimetric chamberDevice
Also called indirect calorimetry
Participants stayed 26h in a calorimetric chamber. They performed a series of physical activities such as walking on a treadmill at different speeds, writing, standing, standing-sitting, stepper , rest , sleeping and eating. They also performed a power test on an ergocycle at different speeds.
Free living conditionsDevice
Also called Doubly labeled water
Volunteers followed the protocol of doubly labeled water to evaluate their energy expenditure during 10 days in free living conditions. For this period, their heart rate, parameters of actimetry and other parameters were recorded.
| Study group | Role | What they receive |
|---|---|---|
| calorimetric chamber | Experimental | Not described Receives: Device: calorimetric chamber |
| Free living conditions | Experimental | Not described Receives: Device: Free living conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure
indirect calorimetry
Measured: one point recorded each minute for 26 hours
Secondary outcomes (5)
energy expenditure
doubly labeled water
Measured: one point at the end of the 10-day period
heart rate
measurements made by electrocardiogram
Measured: one point recorded each minute for 26 hours or 10 days
Accelerometry
uniaxial and biaxial measurements
Measured: one point by minute for 26 hours or 10 days
hunger and emotional state perception
validated questionnaires (Hunger and brief mood introspective scale)
Measured: evaluation before and after each meal
hedonic evaluation of 6 food products
home made questionnaire
Measured: before and after each meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer SimulationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Responsible party
- Sponsor
- Investigators
- Yves Boirie, MD-PhD, Principal investigator, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209572
- Sponsor's protocol ID
- AU767
- Other IDs
- IDRCB 2009-A00912-53
- Acronym
- Modelheart
- Status last verified
- Sep 2010
- First submitted
- 24 Sep 2010
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling of 24h Energy Expenditure From Heart Rate, Actimetry and Other Parameters Recorded Under Free-living Conditions
- ClinicalTrials.gov ID
- NCT01209572
- Acronym / sponsor ID
- Modelheart / AU767
- Conditions
- Computer Simulation, Energy Expenditure, Energy Metabolism
- Keywords
- energy expenditure, heart rate, accelerometry, body temperature, heat flow galvanic response of skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne, Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Sep 2010 (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.
At this time, 24h energy expenditure is rarely assessed under free-living conditions for specific individuals because of the lack of cheap and accurate software/materials to record the energy expenditure. Some affordable and convenient tools (Polar heart rate monitor, Actiheart, SenseWear Armband) are available on the market but the predictive equations comprised into the software provided with these tools generally miscalculate the energy expenditure (by about +/-10%). Because of this deficiency, the investigators have a poor knowledge of the modification of the energy expended during daily life activities and over 24h in subjects belonging to groups of various ages and physiological states. The investigators hypothesise that it could be possible to improve the energy expenditure prediction.
The project aims at providing a mathematical model (equations) that predicts energy expenditure with an error near to 5%. Two groups of 60 sedentary to athletic normal weight volunteers aged between 18-60 years participate to this study. The first group stay for 26h in calorimetric chambers. During this stay energy expenditure ,heart rate, accelerometry, and other parameters are recorded during various activities. These data will serve to construct the model. The same type of recordings are performed on second group of volunteers in free living conditions. Their energy expenditure is measured overall by doubly labeled water. The data of the second group will serve to validate the model. The error percentage of the model is defined by the ratio of the value of the difference between prediction and reference measure to the reference measure. Concordance between predictions and measures will be evaluated by Bland - Altman plots.
Detailed description
All the volunteers have a visit of inclusion in the Centre de Recherche en Nutrition Humaine. During this visit, the volunteers are informed of the methods of the protocol, the taking of samples, the disadvantages and constraints, on the basis of information letter. They have a medical interrogation and a complete clinical examination by an investigatory doctor or Co-investigator. The biological assessment is requiring 10 ml of blood and including: the analysis of the TSH, a blood count, a sedimentation test. Moreover, for the women in age to procreate, the analysis of the beta - HCG is made. To take another blood sample (10 ml) is necessary for the realization of serology HIV/HCV in the volunteers of the group of doubly labeled water, who provide samples of urine and saliva. The results are communicated to the volunteers confidentially.
Following the visit of inclusion and the signature of the consent form, a food consumption survey is performed to evaluate the energy intakes of the volunteers. Moreover, the body composition and the level of physical-activity of the volunteers are evaluated by biphotonic absorptiometry (DEXA) and using questionnaire MAQ (Modifiable Activity Questionnaire, translated and adapted by Vuillemin and Al, 1999), respectively.
The volunteers of the first group (60) performed a maximal aerobic power test on ergocycle to evaluate their maximum aerobic physical capacity (VO2max), in a hospital laboratory. A measurement of the body composition by biphotonic absorptiometry is also carried out to determine their lean and fat mass. Then, the volunteers stay 26 hours in calorimetric rooms (one evening, one night and a day). The data of indirect calorimetry (O2 consumption and production of CO2), heart rate , actimetry and other parameters are taken into account as from midnight. After one night of sleep, the individuals have to carry out series of state or exercises simulating the daily physical-activities (sleeping, writing 15 min, standing-sitting 5 min, standing 15 min, strolling 15 min, rest 20 min, eating 20 min, household 20 min, stepper 20 min, walking on treadmill at increasing speed 3 km/h, 4 km/h, 5 km/h and 6 km/h during 20 minutes). The volunteers have also to answer questionnaires on their perception of hunger, their emotional state and their visual appreciation of 6 food products at 5 times of the day (before and after the breakfast, before and after the lunch and about 16:30 pm). The rest of the time, their activities are free (watching TV, reading, listening radio …). Measurements finish towards 18:00 and volunteers go home. The meals are balanced in proteins/glucides/lipids and cover energy needs. The menus are established by the dieticians. The meals in calorimetric room are prepared in double weighing to make it possible to calculate the actual quantities.
The second group of volunteers (60) follow the protocol of doubly labeled water to evaluate their energy expenditure during 10 days in free living conditions. For this period, their heart rate, parameters of actimetry and other parameters are recorded . The participants of this second group also answer the questionnaires of perception of hunger, emotional state and visual appreciation of 6 food products, over one day at home. The physical data recorded on this second group will be introduced into the predictive equations. The estimated energy expenditure will be compared with the energy expenditure measured by the technique of doubly labeled water. The answers to the questionnaires filled out by the volunteers of the two groups will be also compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calorimetric chamber | Experimental | Device: calorimetric chamber |
| Free living conditions | Experimental | Device: Free living conditions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- men and women
- age: 18-60 years
- BMI between 19 and 25 kg/m²
- subject considered as healthy after clinical examination and medical questionnaire
- subject giving his/her written informed consent
Key exclusion criteria (17 listed)
- biological results judged abnormal by investigator
- positive serologies to HIV or HCV
- respiratory failure or cardiovascular problem
- taking medicine : beta blockers, corticoids, anti-inflammatory drug, thyroid hormones, insulin
- abnormal ECG
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 |
|---|---|---|
| calorimetric chamberAlso: indirect calorimetryParticipants stayed 26h in a calorimetric chamber. They performed a series of physical activities such as walking on a treadmill at different speeds, writing, standing, standing-sitting, stepper , rest , sleeping and eating. They also performed a power test on an ergocycle at different speeds. | Device | calorimetric chamber |
| Free living conditionsAlso: Doubly labeled waterVolunteers followed the protocol of doubly labeled water to evaluate their energy expenditure during 10 days in free living conditions. For this period, their heart rate, parameters of actimetry and other parameters were recorded. | Device | Free living conditions |
Primary outcome
energy expenditure
Time frame: one point recorded each minute for 26 hours
indirect calorimetry
5 secondary outcomes
energy expenditure
Time frame: one point at the end of the 10-day period
heart rate
Time frame: one point recorded each minute for 26 hours or 10 days
Accelerometry
Time frame: one point by minute for 26 hours or 10 days
hunger and emotional state perception
Time frame: evaluation before and after each meal
hedonic evaluation of 6 food products
Time frame: before and after each meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- research fields of the InstituteLink provided by the sponsor.
- Research fields of CRNHLink provided by the sponsor.
Related trials for Computer Simulation
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruiting
SELF-ASSESSMENT AND KNOWLEDGE LEVEL OF NURSING STUDENTS' PATIENT SAFETY COMPETENCY
Simulation Training, Nursing Education
RecruitingObservational study
Anomalous Aortic Origin of Coronary Artery
Anomalous Aortic Origin of the Coronary Artery (AAOCA)
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.
Yves Boirie, MD-PhD principal investigator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calorimetric chamber and Free living conditions in people with Computer Simulation and Energy Expenditure, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 6 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
energy expenditure (time frame: one point recorded each minute for 26 hours). 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 6 Oct 2025.