Energy Expenditure Responses to Different Temperatures

NCT01568671 | Completed

• 2 other identifiers: 12009712-DK-0097
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Normal Physiology

Keywords

Adult; Body Composition; Accelerometry; Healthy Volunteers; Thermoregulation; Natural History; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Resting energy expenditure

  Resting energy expenditure at the lowest tolerable temperature above basal metabolic rate (%), measured by metabolic chamber

  Days 7-13 of inpatient stay

Secondary Outcomes (1)

• Mean skin temperature

  Days 1-14

Study Arms (5)

Healthy older lean white men

EXPERIMENTAL

White men aged 55-75 years with BMI between 18.5 and 25.0 kg/m2

Other: Room temperatures

Healthy young lean black men

EXPERIMENTAL

Black men aged 18-35 years with BMI between 18.5 and 25.0 kg/m2

Other: Room temperatures

Healthy young lean white men

EXPERIMENTAL

White men aged 18-35 years with BMI between 18.5 and 25.0 kg/m2

Other: Room temperatures

Healthy young lean white women

EXPERIMENTAL

White women aged 18-35 years with BMI between 18.5 and 25.0 kg/m2

Other: Room temperatures

Healthy young white men with obesity

EXPERIMENTAL

White men aged 18-35 years with BMI between 30.0 and 40.0 kg/m2

Other: Room temperatures

Interventions

Room temperatures OTHER

Room temperature of metabolic chamber set between 16C and 31C

Healthy older lean white men; Healthy young lean black men; Healthy young lean white men; Healthy young lean white women; Healthy young white men with obesity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 flashes)
• For pre-menopausal women, irregular periods or polycystic ovarian disease

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

• Nedergaard J, Bengtsson T, Cannon B. Unexpected evidence for active brown adipose tissue in adult humans. Am J Physiol Endocrinol Metab. 2007 Aug;293(2):E444-52. doi: 10.1152/ajpendo.00691.2006. Epub 2007 May 1.

  PMID: 17473055 BACKGROUND

• Virtanen KA, Lidell ME, Orava J, Heglind M, Westergren R, Niemi T, Taittonen M, Laine J, Savisto NJ, Enerback S, Nuutila P. Functional brown adipose tissue in healthy adults. N Engl J Med. 2009 Apr 9;360(15):1518-25. doi: 10.1056/NEJMoa0808949.

  PMID: 19357407 BACKGROUND

• van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.

  PMID: 19357405 BACKGROUND

• Ouwerkerk R, Hamimi A, Matta J, Abd-Elmoniem KZ, Eary JF, Abdul Sater Z, Chen KY, Cypess AM, Gharib AM. Proton MR Spectroscopy Measurements of White and Brown Adipose Tissue in Healthy Humans: Relaxation Parameters and Unsaturated Fatty Acids. Radiology. 2021 May;299(2):396-406. doi: 10.1148/radiol.2021202676. Epub 2021 Mar 16.

  PMID: 33724063 DERIVED

• Brychta RJ, Huang S, Wang J, Leitner BP, Hattenbach JD, Bell SL, Fletcher LA, Perron Wood R, Idelson CR, Duckworth CJ, McGehee S, Courville AB, Bernstein SB, Reitman ML, Cypess AM, Chen KY. Quantification of the Capacity for Cold-Induced Thermogenesis in Young Men With and Without Obesity. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4865-4878. doi: 10.1210/jc.2019-00728.

  PMID: 31150063 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kong Y Chen, Ph.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 2, 2012
• Study Start: April 24, 2012
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: June 8, 2026

Record last verified: 2025-10-14

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From the time of publication and available indefinitely
• Access Criteria: Data will be shared with qualified investigators who provide a protocol with IRB approval. Data sharing requires a signed data use agreement.

Locations

US (1)