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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in France

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.

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 groups in NCT01209572
Study groupRoleWhat they receive
calorimetric chamberExperimentalNot described
Receives: Device: calorimetric chamber
Free living conditionsExperimentalNot described
Receives: Device: Free living conditions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. energy expenditure

    indirect calorimetry

    Measured: one point recorded each minute for 26 hours

Secondary outcomes (5)
  1. energy expenditure

    doubly labeled water

    Measured: one point at the end of the 10-day period

  2. heart rate

    measurements made by electrocardiogram

    Measured: one point recorded each minute for 26 hours or 10 days

  3. Accelerometry

    uniaxial and biaxial measurements

    Measured: one point by minute for 26 hours or 10 days

  4. hunger and emotional state perception

    validated questionnaires (Hunger and brief mood introspective scale)

    Measured: evaluation before and after each meal

  5. 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.

  1. First posted27 Sep 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionNov 2009
  4. Study completionSep 2010

Resources

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)
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

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.

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