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Thermoregulatory behavior.


- candidate number13138
- NTR NumberNTR3524
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jul-2012
- Secondary IDs11-3-065 / NL38216.068.11; METC / CCMO
- Public TitleThermoregulatory behavior.
- Scientific TitleRelation between thermo-physiology and behavioral control of body temperature.
- ACRONYM
- hypothesisThe intention to change behavior is related to changes in multiple physiological variables. Thermal comfort and thermal sensation are related to these physiological parameters. Furthermore, the intention of behavior is related to changes in thermal comfort and thermal sensation.
- Healt Condition(s) or Problem(s) studiedThermoregulation, Thermal comfort, Thermal sensation
- Inclusion criteria1. Caucasian healthy females on oral contraceptive;
2. Age: 18 to 30 years;
3. BMI: 20-25;
4. Fat percentage: 20-30%.
- Exclusion criteria1. Regular medication use;
2. Pregnancy;
3. Hypertension (systolic/diastolic blood pressure >140/90);
4. Hypotension (systolic/diastolic blood pressure <90/60);
5. General feeling of illness at day of experiment;
6. (History of) cardiovascular diseases;
7. In the presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease;
8. A history of disorders or impairement of the gag reflex;
9. Previous gastrointestinal surgery;
10. Hypo motility disorders of the gastrointestinal tract including but not limited to Illeus.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2012
- planned closingdate1-jan-2013
- Target number of participants16
- InterventionsCold and heat exposure during three trials:
1. Protocol A is composed of a neutral-to-warm transition in ambient temperature (24C to 32C, with 4 K/h);
2. Protocol B is composed of a neutral-to-cold transition in ambient temperature (24C to 16C, with 4 K/h);
3. During protocol C ambient temperature will be varied between three fixed temperatures (16C, 24C and 32C).
- Primary outcome1. The intention of thermoregulatory behavior, using a questionnaire;
2. Energy expenditure, as measured using indirect calorimetry in a climate controlled respiration chamber.
- Secondary outcome1. Thermal comfort, using a questionnaire with a VAS;
2. Thermal sensation, using a questionnaire with a VAS;
3. Thermal environment, using a questionnaire with a VAS;
4. Skin temperature, using iButtons;
5. Core temperature, using an ingestible pill;
6. Skin perfusion, using Laser Doppler Flowmetry;
7. Blood parameters.
- TimepointsParticipants will be instructed for a 24-hour measurement at home (1 hour) and will visit the research facility three times for 3.5 hour.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Christel Jacquot
- CONTACT for SCIENTIFIC QUERIESPhD. Wouter Marken Lichtenbelt, van
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
AgentschapNL
- PublicationsN/A
- Brief summaryThe volunteers will be measured at home and in an experimental setting where they will be exposed to heat and cold during three different trails. This will be done in order to study the effect of physiological parameters on thermoregulatory behavior, and on thermal comfort and sensation.
- Main changes (audit trail)
- RECORD12-jul-2012 - 5-aug-2012


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