Healthy VolunteersIMPETRAILNCT01906203
Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance
A study testing 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 in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participation to ultramarathon
Who cannot join
- pregnancy women
Trial locations and contacts
1 site in 1 country.
About this study
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.
Read the detailed 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.
- Conditions
- Healthy Volunteers
- Being tested
- 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
- Keywords
- Ultramarathon, bioelectrical impedance, Phase-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, FranceDevice
| Study group | Role | What they receive |
|---|---|---|
| ultramarathon | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of fat-free mass, using bioelectrical impedance analysis
Measured: before and after ultramarathon of 105 km (at day 1)
Secondary outcomes (2)
Difference of phase angle, using bioelectrical impedance analysis
Measured: at day 1(before and after ultramarathon)
Correlation between order in the course,duration of course and indices of body composition
Measured: at day 1 (during ultramarathon of 105 km)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Estaing
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906203
- Sponsor's protocol ID
- CHU-0163
- Acronym
- IMPETRAIL
- Status last verified
- Nov 2014
- First submitted
- 11 Jul 2013
- Last updated
- 26 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance
- ClinicalTrials.gov ID
- NCT01906203
- Acronym / sponsor ID
- IMPETRAIL / CHU-0163
- Conditions
- Healthy Volunteers
- Keywords
- Ultramarathon, bioelectrical impedance, Phase-Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Estaing
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultramarathon | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation to ultramarathon
Key exclusion criteria (1 listed)
- pregnancy women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | ultramarathon |
Primary outcome
Difference of fat-free mass, using bioelectrical impedance analysis
Time frame: before and after ultramarathon of 105 km (at day 1)
2 secondary outcomes
Difference of phase angle, using bioelectrical impedance analysis
Time frame: at day 1(before and after ultramarathon)
Correlation between order in the course,duration of course and indices of body composition
Time frame: at day 1 (during ultramarathon of 105 km)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of fat-free mass, using bioelectrical impedance analysis (time frame: before and after ultramarathon of 105 km (at day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.