Energy Expenditure Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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