Stimulation of Diet-Induced Thermogenesis by Cold-Exposure (NCT01898949) | Clinical Trial Compass
CompletedNot Applicable
Stimulation of Diet-Induced Thermogenesis by Cold-Exposure
United States9 participantsStarted 2010-11
Plain-language summary
Human fat tissue is essentially white fat, the main function of which is to store excess energy intake, and to release it when necessary. Brown fat is far less abundant and is present in the body to burn fat (and thus energy) to generate heat to maintain body temperature around 96 degrees. This phenomenon is called thermogenesis. When humans are exposed to cold on a chronic basis, brown fat expands and becomes more active, and consequently burns more energy. The amount of brown fat is higher during winter, and daily short (20 minutes) exposures to cold might be sufficient to induce its activity.
We hypothesized that daily short term (20 minutes) exposure to a cold environment (4 °C) for four weeks increases adaptive BAT-mediated thermogenesis. CIT and DIT will be increased proportionally (the increase in CIT and DIT will be correlated).
Who can participate
Age range
18 Years – 35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men between the ages of 18-35 years, inclusive
* Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive, with a stable weight (\<2kg variation) within the past 3-6 months
* Non smokers
* On no medication or recreational drugs
* Healthy as assessed by a standard self-reported screening health questionnaire
* Provide written informed consent
Exclusion Criteria:
* Smokers
* Individuals taking any medications
* Individuals taking any stimulants
* Individuals taking beta-blockers
* Individuals with diabetes or impaired fasting glucose as defined by theADA criteria, i.e. fasting plasma glucose concentration ≥ 5.6 mmol/L (100 mg/dl).
* Individuals with chronic alcohol consumption (\> 3 drinks per day) or drug abuse
* Individuals unable to abstain from caffeinated beverage or alcohol the days of study
* Individuals with pacemakers or defibrillators
* Individuals with history of heart disease or history of stroke
* Individuals having a significant recent loss or gain of weight
* Individuals involved in regular (\> 3 times per week), intense competitive sporting activities.
* Individuals involved in intensive exercise activity.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.