NCT01209572

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2010

Enrollment Period

10 months

First QC Date

September 24, 2010

Last Update Submit

October 1, 2025

Conditions

Keywords

energy expenditureheart rateaccelerometrybody temperatureheat flow galvanic response of skin

Outcome Measures

Primary Outcomes (1)

  • energy expenditure

    indirect calorimetry

    one point recorded each minute for 26 hours

Secondary Outcomes (5)

  • energy expenditure

    one point at the end of the 10-day period

  • heart rate

    one point recorded each minute for 26 hours or 10 days

  • Accelerometry

    one point by minute for 26 hours or 10 days

  • hunger and emotional state perception

    evaluation before and after each meal

  • hedonic evaluation of 6 food products

    before and after each meal

Study Arms (2)

calorimetric chamber

EXPERIMENTAL
Device: calorimetric chamber

Free living conditions

EXPERIMENTAL
Device: Free living conditions

Interventions

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.

Also known as: indirect calorimetry
calorimetric chamber

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.

Also known as: Doubly labeled water
Free living conditions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Nutrition Humaine d'Auvergne

Clermont-Ferrand, Auvergne, 63009, France

Location

Related Links

MeSH Terms

Interventions

Calorimetry, Indirect

Intervention Hierarchy (Ancestors)

CalorimetryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Yves Boirie, MD-PhD

    Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 27, 2010

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

September 1, 2010

Last Updated

October 6, 2025

Record last verified: 2010-09

Locations