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NCT01906203 Clinical Trial

Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance

Healthy Volunteers Clinical Trial

— IMPETRAIL  

Official title:
Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01906203
Other study ID # CHU-0163
Secondary ID
Status Completed
Phase N/A
First received July 11, 2013
Last updated November 25, 2014
Start date May 2013
Est. completion date September 2013

Study information
Verified date November 2014
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

Description:

Prospective, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis (phase angle, fat mass, muscle mass, fat-free mass, body water) before and after ultramarathon.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participation to ultramarathon

Exclusion Criteria:

- pregnancy women

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, France

Locations
Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand University Hospital, Estaing

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference of fat-free mass, using bioelectrical impedance analysis before and after ultramarathon of 105 km (at day 1) Yes
Secondary Difference of phase angle, using bioelectrical impedance analysis at day 1(before and after ultramarathon) Yes
Secondary Correlation between order in the course,duration of course and indices of body composition at day 1 (during ultramarathon of 105 km) Yes
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