NCT00848471

Brief Summary

Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark RMR versus Deltatrac II

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

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
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

February 19, 2009

Last Update Submit

August 18, 2009

Conditions

HealthyObesity

Keywords

Indirect calorimeterValidationEnergy expenditureHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure at rest in standardized conditions

    At the end of the study

Secondary Outcomes (1)

  • To compare the results obtained for the Deltatrac II and the Quark RMR for the measure of energy expenditure after a food intake of 600kcal

    At the end of the study

Study Arms (2)

1

EXPERIMENTAL

Quark RMR calorimeter (Cosmed)

Device: Quark RMR

2

ACTIVE COMPARATOR

Deltatrac II (GE health Care Clinical Systems)

Device: Deltatrac II

Interventions

Quark RMRDEVICE

Quark RMR calorimeter (Cosmed)

1
Deltatrac IIDEVICE

Deltatrac II (GE health Care Clinical Systems)

2

Eligibility Criteria

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

You may qualify if:

  • to 60 years old
  • BMI between 20 and 35 kg/m²
  • Weight stable for at least 2 months
  • Safety subject during medical consultation
  • Normal TSH -CRP -glycemia - creatinin

You may not qualify if:

  • Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflamatory diseases)
  • Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)
  • Eating disorder
  • Intensive sportive activity (Baecke's score \>5)
  • Subjects who Smoke
  • Claustrophobic subjects
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Nutrition Rhône Alpes, Hôpital Edouard Herriot

Lyon, Rhone-Alps, 69424, France

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martine LAVILLE, M.D

    Hôpital Edouard Herriot

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Secretary, Centre de Recherche en Nutrition Rhône Alpes

CONTACT

04.72.11.07.08secretariat.crnh@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

FR(1)