Energy Expenditure Responses to Different Temperatures (NCT01568671) | Clinical Trial Compass
CompletedNot Applicable
Energy Expenditure Responses to Different Temperatures
United States104 participantsStarted 2012-04-24
Plain-language summary
Background:
\- The way that the body burns calories is known as energy expenditure. Some studies show that when we are cold, we burn more calories to keep our bodies warm. Brown fat is a special kind of fat that can use energy to keep the body warm. Small animals and infants have been known to have brown fat for many years. Recently, it has been suggested that adult humans also have brown fat. If brown fat becomes active (burns calories) in adult humans when exposed to cold, then these people would tend to burn off more calories and might not gain weight easily. Learning more about the relationship between energy expenditure, brown fat, environmental temperature, and body temperature may help explain why some people become obese and other people do not.
Objectives:
* To better understand how the body burns calories when exposed to different temperatures.
* To study brown fat and how it burns calories in cold temperatures.
Eligibility:
* Healthy men between 18 and 35 or 55 and 75 years of age.
* Healthy women between 18 and 35 years of age.
* To control for ethnicity, participants must be non-Hispanic whites or African Americans.
Design:
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
* Participants will stay in the Metabolic Unit of the National Institutes of Health Clinical Center as inpatients for no more than 14 days. The length of the hospital stay will depend on how participants respond to the different study temperatures.
* Every afternoon, participants will walk for 30 minutes on a treadmill. All meals will be provided.
* Participants will stay up to 5 hours per day in a specialized room with different temperature settings. Temperatures will range from about 61 degrees to 88 degrees Fahrenheit. Body temperature, activity, calorie burning, and cold/hot sensations will be monitored. On the study day of the coldest temperature, participants will have an imaging study to look for brown fat activity.
* Participants will be compensated for their time and participation at the end of the study....
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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:
* Generally healthy.
* Males between the age greater than or equal to 18 -35 years or between 55-75 years, male orand females between the age 18-35 years.
* Self-reported non-Hispanic and non-Latino Caucasian and African-Americans
* Written informed consent.
EXCLUSION CRITERIA:
* Hypo- or hyper-thyroid (history or TSH \>5.0\<0.4 miU/L)
* Psychological conditions,such as (but not limited to) claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study
* Weight change \>5% in the past 6 months or a trained athlete
Blood pressure greater than 140/90 mmHg or current antihypertensive therapy
* History of cardiovascular disease
* BMI \<18.5, between 25.1-29.9, and \>40 Kg/m(2)
* Diabetes mellitus (fasting serum glucose \> 126 mg/dL)
* Liver disease or ALT serum level greater than two times the laboratory upper limit of normal
* Iron deficiency (Ferritin \< 30 mcg/L males, \< 15 mcg/L females)
* Abnormal kidney function (eGFR\<60 ml/min/1.73m(2))
* History of illicit drug or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE greater than or equal to 2)
* Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism
* Pregnancy/breastfeeding/hormonal contraception or childbirth within the last year
* Perimenopausal (as self-described within two years from onset of amenorrhea or current complaints of hot fla…
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.
What they're measuring
1
Resting energy expenditure
Timeframe: Days 7-13 of inpatient stay
Trial details
NCT IDNCT01568671
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)