Primary objectives: this study will 1) assess the accuracy of the Cortex MetaLyzer® 3B in adolescents (12-17 yr) for measuring REE, using the Deltatrac® II metabolic monitor as a reference; and 2) assess the accuracy and the within-subject, within-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
N.v.t.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the VO2 (ml/min), VCO2 (ml/min) and RQ which are
measured with alternating use by the indirect calorimeters. These parameters
make it possible to calculate REE (MJ/day), which is the primary endpoint.
Secondary outcome
The parameters weight (kg), height (m), and body mass index (BMI, kg/m2) are
measured by scale and stadiometer. With these parameters the REE (MJ/day) can
be derived using the prediction equations. The predicted REEs are compared with
the measured REEs.
Background summary
The estimation of energy expenditure in an individual is essential in
nutritional assessment, to determine energy requirements. In practice, energy
requirements are often estimated, by experts, through prediction equations.
However, these equations are lacking accuracy on the individual level due to
high variation of many covariates, both in adolescents and adults.
Indirect calorimetry is seen as a gold standard for measuring energy
expenditure. By using indirect calorimeters, the energy expenditure is
determined by measuring oxygen consumption (VO2) and carbon dioxide production
(VCO2).
In clinical practice, indirect calorimetry is the most preferable method to
use. Unfortunately, traditional indirect calorimeters are cumbersome, require
skilled operators, and are costly to maintain. Therefore, it is desirable to
test existing, portable indirect calorimeters on accuracy.
Study objective
Primary objectives: this study will 1) assess the accuracy of the Cortex
MetaLyzer® 3B in adolescents (12-17 yr) for measuring REE, using the Deltatrac®
II metabolic monitor as a reference; and 2) assess the accuracy and the
within-subject, within-day repeatability of the MedGem® in adults (18-65 yr)
for measuring REE, using the Deltatrac® II metabolic monitor as a reference.
Secondary objective: evaluate frequently used prediction equations by comparing
measured REE*s with predicted REE*s.
Study design
The study will have a crossover design. REE (in MJ/day) measurements will be
performed during one session, with alternating use of either the Cortex
MetaLyzer® 3B (facemask) or the portable MedGem® (mouthpiece) with the
Deltatrac® II metabolic monitor (ventilated-hood) as a reference method.
Furthermore, body composition measurements by bio-impedance spectroscopy (BIS)
and body weight and height measurements will be conducted.
Intervention
Not applicable
Study burden and risks
All measurements, with indirect calorimeters, bio-impedance spectroscopy and
anthropometry device, are safe and non-invasive. This study is in no way
burdensome for the participants. The benefits of using indirect calorimetry is
that energy expenditure of an individual can be accurately determined. This
study will test the accuracy of indirect calorimeters in apparently healthy
individuals.
This study is regarded as group-related, since it has been designed in response
to an inquiry of the Wilhelmina Children's Hospital in Utrecht. Without
contribution of apparently healthy adolescents with approval of their
parents/guardians, the study cannot be conducted.
gebouw 124, Stippeneng 4
Wageningen 6708 WE
NL
gebouw 124, Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
- apparently healthy (self-indicated);
- adolescents 12-17 years of age;
- adults 18-65 years of age.
Exclusion criteria
- adults with a BMI <18.5 or >30;
- pregnancy;
- having self-indicated claustrophobia or respiratory problems e.g. due to a common cold;
- having a pacemaker;
- participating in other scientific research.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60001.081.16 |