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Room Temperature Effects on Calorie Burn in Obesity
N/A
Recruiting
Led By Kong Y Chen, Ph.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females between the age 18-35 years
Be older than 18 years old
Must not have
Psychological conditions such as claustrophobia, clinical depression, bipolar disorders that would be incompatible with safe and successful participation in this study
Blood pressure greater than 140/90 mmHg or current antihypertensive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 7-13 of inpatient stay
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how the body burns calories when exposed to different temperatures and how brown fat burns calories in cold temperatures.
Who is the study for?
Healthy men aged 18-35 or 55-75 and healthy women aged 18-35, who are non-Hispanic whites or African Americans. Excluded are those with high blood pressure, certain BMI ranges, diabetes, abnormal kidney function, recent drug/alcohol abuse, metal implants incompatible with MRI scans, cardiovascular disease, liver disease, iron deficiency and other specific health conditions.
What is being tested?
The study is examining how the body's energy expenditure changes in response to different room temperatures ranging from about 61°F to 88°F. It aims to understand the role of brown fat in calorie burning during cold exposure by monitoring body temperature and activity levels.
What are the potential side effects?
There may be minimal side effects since this trial involves environmental temperature changes rather than medication or invasive procedures. However participants might experience discomfort due to cold or hot sensations when exposed to varying temperatures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged between 18 and 35.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have psychological conditions like claustrophobia or bipolar disorder that would prevent my safe participation.
Select...
My blood pressure is over 140/90 mmHg or I am on medication for high blood pressure.
Select...
I have a history of heart disease.
Select...
I have diabetes with a fasting blood sugar over 126 mg/dL.
Select...
My liver is not functioning properly, or my ALT levels are high.
Select...
My kidney function is below normal levels.
Select...
I am currently using products that change how my body uses energy.
Select...
I am a pre-menopausal woman with irregular periods or polycystic ovarian disease.
Select...
My thyroid levels are not normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 7-13 of inpatient stay
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 7-13 of inpatient stay
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Resting energy expenditure
Secondary study objectives
Thermography
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Healthy young white men with obesityExperimental Treatment1 Intervention
White men aged 18-35 years with BMI between 30.0 and 40.0 kg/m2
Group II: Healthy young lean white womenExperimental Treatment1 Intervention
White women aged 18-35 years with BMI between 18.5 and 25.0 kg/m2
Group III: Healthy young lean white menExperimental Treatment1 Intervention
White men aged 18-35 years with BMI between 18.5 and 25.0 kg/m2
Group IV: Healthy young lean black menExperimental Treatment1 Intervention
Black men aged 18-35 years with BMI between 18.5 and 25.0 kg/m2
Group V: Healthy older lean white menExperimental Treatment1 Intervention
White men aged 55-75 years with BMI between 18.5 and 25.0 kg/m2
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,464 Previous Clinical Trials
4,337,333 Total Patients Enrolled
2 Trials studying Normal Physiology
2,120 Patients Enrolled for Normal Physiology
Kong Y Chen, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 Previous Clinical Trials
2,446 Total Patients Enrolled
1 Trials studying Normal Physiology
2,000 Patients Enrolled for Normal Physiology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged between 18 and 35.I do not have psychological conditions like claustrophobia or bipolar disorder that would prevent my safe participation.My blood pressure is over 140/90 mmHg or I am on medication for high blood pressure.I have a history of heart disease.I have diabetes with a fasting blood sugar over 126 mg/dL.My liver is not functioning properly, or my ALT levels are high.My kidney function is below normal levels.I am currently using products that change how my body uses energy.I am experiencing symptoms of menopause.I am a pre-menopausal woman with irregular periods or polycystic ovarian disease.I am a man aged 18-35 or 55-75.My thyroid levels are not normal.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy older lean white men
- Group 2: Healthy young lean black men
- Group 3: Healthy young lean white men
- Group 4: Healthy young lean white women
- Group 5: Healthy young white men with obesity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.