search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Thermal challenges in modern day humans


- candidate number22975
- NTR NumberNTR5551
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2015
- Secondary IDsMETC153039 NL54274.068.15
- Public TitleThermal challenges in modern day humans
- Scientific TitleThermal challenges in modern day humans
- ACRONYMTCMDH
- hypothesisThis study aims to chart which thermal challenges modern day humans are exposed to and compare this to their thermoneutral zone. Therefore we hypothesize that modern day humans (both males and females) are predominantly within their thermoneutral zone
- Healt Condition(s) or Problem(s) studiedHealthy volunteers
- Inclusion criteria Age between 18 and 60 years old
BMI between 20 to 25 kg/m2
Sharing the same office with another participant of different gender.
- Exclusion criteria Is a minor or senior (i.e. younger than 18 years or older than 60 years)
Age difference within couple greater than 10 years
BMI difference within couple greater than 2 BMI points
Health issues as observed by general health questionnaire (appendix F1.1)
Within couple at least 1 participant works more than 1 night-shift per month (appendix F1.2)
Incapacitated
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2015
- planned closingdate1-apr-2017
- Target number of participants20
- InterventionsDuring the field study subjects are encouraged to behave as they normally would, therefore no intervention is planned. During the laboratory visit the thermal environment of subjects is altered by changing clothing conditions while subjects perform several activities (sitting walking) on a treadmill
- Primary outcomeThe main study parameter is the fraction of time spent relative to the thermoneutral zone. The distance from the thermoneutral zone is defined by comparing measured skin temperature and operative temperature to the theoretical centroid of the thermoneutral zone.
- Secondary outcomeThe secondary research questions relate to the primary objectives and aim to give insight in how the thermal states are related to physical and physiological parameters:

Physiological
o Metabolic rate distinguished by:
Basal metabolic rate
Activity level
o Insulation distinguished by:
Body composition
Skin blood flow
Physical
o Thermal environment by:
Air temperature
Humidity
Clothing
Subjective
o Thermal comfort
- Timepoints1 lab day and 2 field days
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Wouter Marken Lichtenbelt, van
- CONTACT for SCIENTIFIC QUERIES Boris Kingma
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
TKI-TRECO
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-okt-2015 - 4-feb-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl