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Thermoregulatory behaviour and mild heat acclimation


- candidate number17502
- NTR NumberNTR4519
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-apr-2014
- Secondary IDsNL47779.068.14  
- Public TitleThermoregulatory behaviour and mild heat acclimation
- Scientific TitleHuman thermoregulatory behavior and thermo-physiology before and after mild heat acclimation in healthy lean and obese subjects
- ACRONYMTRB_ACCL
- hypothesis1. There are differences of thermoregulatory behavior and thermo-physiology between healthy lean and obese subjects.
2. Healthy lean and obese individuals can be classified based on individual thermal preference, which is a result of distinct thermoregulatory behavior and thermo-physiology.
3. A seven-day mild heat acclimation affects thermal physiology, alertness and cardiovascular health of healthy lean and obese subjects.
- Healt Condition(s) or Problem(s) studiedThermoregulation, Acclimatisation
- Inclusion criteriaCaucasian healthy lean volunteers
Generally healthy
male or female
Age: 18 to 35 years
BMI: 20-25 kg/m2
Women using Microgynon 30 or levonorgestrel/ehinylestradiol


Inclusion criteria obese volunteers
Generally healthy
male or female
Age 18 to 35 years
BMI 28-35 kg/m2
Women using Microgynon 30 or levonorgestrel/ethinylestradiol
- Exclusion criteria Participants that do not want to be informed about accidental medical findings, which might occur during the study.
o If participants do not want us to inform their general practitioners about unexpected medical findings, they cannot participate in the study.

Participate in physical activity more than 2x/week
o We will exclude individuals that participate in endurance sports (like swimming, running, cycling) more than two hours per week. Endurance-trained athletes seem to have differing thermo-physiology, which has, amongst others, been recently confirmed by another study of our laboratory (Vosselman et al, submitted).
Participation in another biomedical study within 1 month before the first screening visit
Diabetes mellitus type I and II
Pregnancy
Unstable weight (weight gain or loss > 5 kg in the last three months)
Hypertension (systolic/diastolic blood pressure >140/90)
Hypotension (systolic/diastolic blood pressure <90/60)
General feeling of illness at day of experiment
(History of) cardiovascular diseases
Contraindications for the telemetric pill:
o In the presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease
o A history of disorders or impairment of the gag reflex
o Previous gastrointestinal surgery
o Hypo motility disorders of the gastrointestinal tract including but not limited to Illeus
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate31-dec-2015
- Target number of participants48
- InterventionsThe study will take place between March 2014 and December 2015. The measurements will be conducted at the Metabolic Research Unit (MRUM) of Maastricht University. The study will consist of 11 testing days at the laboratory (Figure 1). Day 1 will consist of a screening. During day 2 and 3, baseline measurements of the so-called SWITCH protocol (experimental protocol to measure thermoregulatory behavior) as well as protocol TNZwarm and TNZcold (thermo-neutral zone measurements) will take place. TNZwarmpre and SWITCHpre will be carried out at the same day (day 2) and TNZcoldpre at a separate day (day 3), followed by the first mild heat exposure. During the next 6 days, participants will visit the laboratory for an acclimation period that consists of 6.5h mild heat exposure per day. After completing day seven of the acclimation, participants will undergo protocol TNZwarm (TNZwarmpost), SWITCH (SWITCHpost) and TNZcold (TNZcoldpost) for a second time.
- Primary outcomethermoregulatory behavior, thermal sensation, thermal comfort, thermo-physiological parameters (energy expenditure, core temperature, skin temperature, skin blood perfusion, local sweat rate, total sweat rate, skin conductance, shivering) and body composition
- Secondary outcomecardiovascular functions such as heart rate, blood pressure, hemodynamic parameters, blood parameters, gross motor activity and alertness
- TimepointsThe study will consist of 11 testing days at the laboratory (Figure 1). Day 1 will consist of a screening. During day 2 and 3, baseline measurements of the so-called SWITCH protocol (experimental protocol to measure thermoregulatory behavior) as well as protocol TNZwarm and TNZcold (thermo-neutral zone measurements) will take place. TNZwarmpre and SWITCHpre will be carried out at the same day (day 2) and TNZcoldpre at a separate day (day 3), followed by the first mild heat exposure. During the next 6 days, participants will visit the laboratory for an acclimation period that consists of 6.5h mild heat exposure per day. After completing day seven of the acclimation, participants will undergo protocol TNZwarm (TNZwarmpost), SWITCH (SWITCHpost) and TNZcold (TNZcoldpost) for a second time.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES H. Pallubinsky
- CONTACT for SCIENTIFIC QUERIES H. Pallubinsky
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
AgentschapNL, Energie Onderzoek Subsidie (EOS)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-apr-2014 - 5-mei-2014


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