HealthyNCT01730105
Chronic Cold Exposure and Energy Metabolism in Humans
An observational study of Healthy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Researchers are studying how metabolism and hormone levels change in response to mild changes in environmental temperature. Changes in metabolism may lessen with time because of hormonal adaptations. If this increase in metabolism continues for a longer period, mild cold exposure may cause weight loss. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Healthy
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2012to 10 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Between 18-40 years old
- Willing to participate and provide informed consent
Who cannot join
- Hypo- or hyper-thyroid (history or TSH greater than 5.0 or less than 0.4 milli-international units per liter)
- Blood pressure greater than 140/90 millimeters of mercury (19) or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 25 kilogram per cubic meter
- Diabetes mellitus or impaired fasting glycemia (fasting serum glucose greater than 100 grams per liter).
- Hypercholesterolemia (serum greater than or equal to 240 levels grams per liter), hypertriglyceridemia (plasma greater than or equal to 220 levels grams per liter) and/or use of antilipemic therapy.
Show all 18Show fewer
- Liver disease or ALT serum level greater than two fold the upper laboratory reference limit.
- Iron deficiency (Ferritin less than 40 nanograms per milliliter males) (20).
- Renal insufficiency or estimated creatinine clearance less than 50 milliliter per minute (MDRD equation).
- Claustrophobia.
- History of illicit drug or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE greater than 3).
- Psychiatric conditions or behavior that would be incompatible with safe and successful participation in this study
- Current use of medications/dietary supplements/alternative therapies known to alter thyroid function.
- Current use of antiplatelet or anticoagulants.
- Allergy to lidocaine.
- Current smoker or user of tobacco products
- Current participation in weight loss programs (dietary, exercise or pharmacological) or more than 3 kg weight changes in last 6 months
- Spending greater than 70% daily hours outdoors
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Impact of Chronic Cold Exposure on Energy Metabolism in Humans
Background:
- Researchers are studying how metabolism and hormone levels change in response to mild changes in environmental temperature. Changes in metabolism may lessen with time because of hormonal adaptations. If this increase in metabolism continues for a longer period, mild cold exposure may cause weight loss. It is unclear whether exposure to a warmer temperature may cause opposite changes in metabolism. Researchers want to see if longer exposure (1 month) to different temperatures can affect how the body uses energy.
Read more
Objectives:
- To test changes in energy metabolism in response to different room temperatures.
Eligibility:
- Healthy men between 18 and 40 years of age.
Design:
- The entire study will last for 4 months. It will involve a screening visit and a 4-month inpatient stay at the National Institutes of Health Clinical Center. The inpatient stay will be in a private room at the Metabolic Clinical Research unit. Study participants will be required to stay in the Metabolic Clinical Research unit during the night, but are free to leave during the day.
- At the screening visit, participants will have a physical exam and medical history. Blood samples will be collected. A heart function test and diet questionnaire will also be given.
- During the first month, the temperature of the private room will be set at to 75.2 degrees F. This will allow the body to become used to the testing environment.
- During the second month, the temperature will be set to either a cool (66.2 degrees F) or a warm (80.6 degrees F) temperature.
- During the third month, the temperature will return to 75.2 degrees F.
- During the fourth month, the temperature will be altered to the opposite temperature to the one set in the second month.
- Throughout stay, participants will have daily temperature monitoring and will keep a food diary. Once a week, they will collect all of their urine for 24 hours. Once a month, they will spend 24 hours in a metabolic suite to study their metabolism rate.
- Throughout stay, the food will be provided as part of the study.
- During the first and third month (75.2 degrees F) the participants will be allowed to leave the Metabolic Clinical Research unit during the weekends, while during the second and forth month (66.2 or 80.6 degrees F), the participants will be allowed to spend one weekend out of the Metabolic Clinical Research unit.
- Other tests, such as body scans, fat tissue samples, and imaging studies, will be performed as needed.
Read the detailed description
Obesity is a major health issue worldwide. Despite global research efforts, effective treatments for obesity are limited. There are two kinds of fat in the body: white fat and brown fat. White fat functions mainly as an energy-storing organ and in excess results in obesity and complications such as diabetes and high blood pressure. Brown fat on the other hand releases the energy stored in fat as heat. It protects small animals and newborn human infants from cold temperatures.
Recent advances in imaging techniques have revealed brown fat to be present in significant amount in adult humans. Using PET scanning, brown fat is shown to be more abundant in lean and younger individuals, suggesting that brown fat may regulate energy balance and metabolism. In a previous study we showed that following exposure to mild cold (19degree C/66degree F), the activity of brown fat was increased by nearly 10% and the energy expenditure by over 6%. Over time, these changes might result in substantial weight loss. However this has not been investigated and it is uncertain whether long-term cold exposure can sustain the increased activity of brown fat. In order to determine the therapeutic potential of brown fat activation, we designed a study investigating the effects of cold exposure over a long period.
We hypothesize that adult humans can be cold-acclimatized through mild cold exposure over a month. Brown fat activity can be increased and sustained by cold stimulation, which could result in beneficial metabolic changes in the body.
The aims of the current project are to:
- determine whether brown fat can be stimulated by exposure to mild cold
- investigate the metabolic consequences of long-term cold exposure
Volunteers will be randomly assigned to sleep overnight in the Metabolic Clinical Research Unit at NIH, set at either mild cold (19degree C/66degree F) or mild warm (27degree C/81degree F), with a lead-in period and a wash-out period before crossing over, during which the temperature will be ambient (24degree C/75 degree F). Volunteers can conduct their regular activities during the day. Each period will be 1 month in duration. At the end of each month, volunteers will be evaluated for their metabolic response to a mild cold challenge for 24 hours (19degree C/66degree F) to determine whether brown fat function and activity have been altered by temperature acclimatization in the previous month.
Significance: Based on its role in energy homeostasis and protection against obesity in animals, brown fat is likely to have a similar role in adult humans. Determining the contribution of brown fat-mediated cold acclimatization to long term energy balance may lead to novel treatment strategies of obesity.
- Conditions
- Healthy
- Keywords
- Adaptive Thermogenesis, Adipose Tissue, Body Composition, Body Weight Regulation, Brown Adipose Tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the inducibility and plasticity of brown adipose tissue activity by chronic mild cold exposure in healthy adults.
Secondary outcomes (2)
Evaluate the metabolic sequelae of chronic mild cold exposure
Evaluate the mechanisms underlying cold-induced metabolic changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start17 Nov 2012
- Primary completion24 Jun 2014
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kong Y Chen, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730105
- Sponsor's protocol ID
- 130013
- Other IDs
- 13-DK-0013
- Status last verified
- 10 May 2018
- First submitted
- 17 Nov 2012
- Last updated
- 14 May 2018
- Results posted
- No
Publications
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.
PubMed 22253364Cowburn G, Hillsdon M, Hankey CR. Obesity management by life-style strategies. Br Med Bull. 1997;53(2):389-408. doi: 10.1093/oxfordjournals.bmb.a011619.
PubMed 9246842Hankey CR. Session 3 (Joint with the British Dietetic Association): Management of obesity: Weight-loss interventions in the treatment of obesity. Proc Nutr Soc. 2010 Feb;69(1):34-8. doi: 10.1017/S0029665109991844. Epub 2009 Dec 15.
PubMed 20003637Lee P, Smith S, Linderman J, Courville AB, Brychta RJ, Dieckmann W, Werner CD, Chen KY, Celi FS. Temperature-acclimated brown adipose tissue modulates insulin sensitivity in humans. Diabetes. 2014 Nov;63(11):3686-98. doi: 10.2337/db14-0513. Epub 2014 Jun 22.
PubMed 24954193
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Cold Exposure on Energy Metabolism in Humans
- ClinicalTrials.gov ID
- NCT01730105
- Acronym / sponsor ID
- 130013
- Conditions
- Healthy
- Keywords
- Adaptive Thermogenesis, Adipose Tissue, Body Composition, Body Weight Regulation, Brown Adipose Tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 17 Nov 2012
- Primary completion
- 24 Jun 2014 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Researchers are studying how metabolism and hormone levels change in response to mild changes in environmental temperature. Changes in metabolism may lessen with time because of hormonal adaptations. If this increase in metabolism continues for a longer period, mild cold exposure may cause weight loss. It is unclear whether exposure to a warmer temperature may cause opposite changes in metabolism. Researchers want to see if longer exposure (1 month) to different temperatures can affect how the body uses energy.
Objectives:
- To test changes in energy metabolism in response to different room temperatures.
Eligibility:
- Healthy men between 18 and 40 years of age.
Design:
- The entire study will last for 4 months. It will involve a screening visit and a 4-month inpatient stay at the National Institutes of Health Clinical Center. The inpatient stay will be in a private room at the Metabolic Clinical Research unit. Study participants will be required to stay in the Metabolic Clinical Research unit during the night, but are free to leave during the day.
- At the screening visit, participants will have a physical exam and medical history. Blood samples will be collected. A heart function test and diet questionnaire will also be given.
- During the first month, the temperature of the private room will be set at to 75.2 degrees F. This will allow the body to become used to the testing environment.
- During the second month, the temperature will be set to either a cool (66.2 degrees F) or a warm (80.6 degrees F) temperature.
- During the third month, the temperature will return to 75.2 degrees F.
- During the fourth month, the temperature will be altered to the opposite temperature to the one set in the second month.
- Throughout stay, participants will have daily temperature monitoring and will keep a food diary. Once a week, they will collect all of their urine for 24 hours. Once a month, they will spend 24 hours in a metabolic suite to study their metabolism rate.
- Throughout stay, the food will be provided as part of the study.
- During the first and third month (75.2 degrees F) the participants will be allowed to leave the Metabolic Clinical Research unit during the weekends, while during the second and forth month (66.2 or 80.6 degrees F), the participants will be allowed to spend one weekend out of the Metabolic Clinical Research unit.
- Other tests, such as body scans, fat tissue samples, and imaging studies, will be performed as needed.
Detailed description
Obesity is a major health issue worldwide. Despite global research efforts, effective treatments for obesity are limited. There are two kinds of fat in the body: white fat and brown fat. White fat functions mainly as an energy-storing organ and in excess results in obesity and complications such as diabetes and high blood pressure. Brown fat on the other hand releases the energy stored in fat as heat. It protects small animals and newborn human infants from cold temperatures.
Recent advances in imaging techniques have revealed brown fat to be present in significant amount in adult humans. Using PET scanning, brown fat is shown to be more abundant in lean and younger individuals, suggesting that brown fat may regulate energy balance and metabolism. In a previous study we showed that following exposure to mild cold (19degree C/66degree F), the activity of brown fat was increased by nearly 10% and the energy expenditure by over 6%. Over time, these changes might result in substantial weight loss. However this has not been investigated and it is uncertain whether long-term cold exposure can sustain the increased activity of brown fat. In order to determine the therapeutic potential of brown fat activation, we designed a study investigating the effects of cold exposure over a long period.
We hypothesize that adult humans can be cold-acclimatized through mild cold exposure over a month. Brown fat activity can be increased and sustained by cold stimulation, which could result in beneficial metabolic changes in the body.
The aims of the current project are to:
- determine whether brown fat can be stimulated by exposure to mild cold
- investigate the metabolic consequences of long-term cold exposure
Volunteers will be randomly assigned to sleep overnight in the Metabolic Clinical Research Unit at NIH, set at either mild cold (19degree C/66degree F) or mild warm (27degree C/81degree F), with a lead-in period and a wash-out period before crossing over, during which the temperature will be ambient (24degree C/75 degree F). Volunteers can conduct their regular activities during the day. Each period will be 1 month in duration. At the end of each month, volunteers will be evaluated for their metabolic response to a mild cold challenge for 24 hours (19degree C/66degree F) to determine whether brown fat function and activity have been altered by temperature acclimatization in the previous month.
Significance: Based on its role in energy homeostasis and protection against obesity in animals, brown fat is likely to have a similar role in adult humans. Determining the contribution of brown fat-mediated cold acclimatization to long term energy balance may lead to novel treatment strategies of obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Between 18-40 years old
- Willing to participate and provide informed consent
Key exclusion criteria (18 listed)
- Hypo- or hyper-thyroid (history or TSH greater than 5.0 or less than 0.4 milli-international units per liter)
- Blood pressure greater than 140/90 millimeters of mercury (19) or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 25 kilogram per cubic meter
- Diabetes mellitus or impaired fasting glycemia (fasting serum glucose greater than 100 grams per liter).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the inducibility and plasticity of brown adipose tissue activity by chronic mild cold exposure in healthy adults.
2 secondary outcomes
Evaluate the metabolic sequelae of chronic mild cold exposure
Evaluate the mechanisms underlying cold-induced metabolic changes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Background: PubMed 22253364Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17.
- Background: PubMed 9246842Cowburn G, Hillsdon M, Hankey CR. Obesity management by life-style strategies. Br Med Bull. 1997;53(2):389-408. doi: 10.1093/oxfordjournals.bmb.a011619.
- Background: PubMed 20003637Hankey CR. Session 3 (Joint with the British Dietetic Association): Management of obesity: Weight-loss interventions in the treatment of obesity. Proc Nutr Soc. 2010 Feb;69(1):34-8. doi: 10.1017/S0029665109991844. Epub 2009 Dec 15.
- Derived from this study: PubMed 24954193Lee P, Smith S, Linderman J, Courville AB, Brychta RJ, Dieckmann W, Werner CD, Chen KY, Celi FS. Temperature-acclimated brown adipose tissue modulates insulin sensitivity in humans. Diabetes. 2014 Nov;63(11):3686-98. doi: 10.2337/db14-0513. Epub 2014 Jun 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kong Y Chen, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the inducibility and plasticity of brown adipose tissue activity by chronic mild cold exposure in healthy adults.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730105, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.