120 Participants Needed

Room Temperature Effects on Calorie Burn in Obesity

Recruiting at 1 trial location
MS
KY
Overseen ByKong Y Chen, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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....

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications, dietary supplements, or alternative therapies that are known to alter energy metabolism before participating in this trial.

What data supports the effectiveness of the treatment Room temperatures on calorie burn in obesity?

The research suggests that energy expenditure can be influenced by factors like body composition and thermogenesis (heat production in the body), which can be affected by room temperature. While not directly about room temperature, studies show that energy expenditure is higher in obese individuals due to increased fat-free mass, and thermogenesis can be stimulated by cold, hinting that room temperature might play a role in calorie burn.12345

Is it safe for humans to be exposed to different room temperatures to study calorie burn in obesity?

The research does not provide specific safety data on room temperature exposure in humans, but it discusses non-invasive methods used in animals to study energy expenditure, which suggests that similar studies in humans could be safe if conducted carefully.46789

How does room temperature affect calorie burn in obesity compared to other treatments?

This treatment is unique because it explores how room temperature can influence calorie burn in obese individuals, unlike traditional treatments that focus on diet or exercise. The study suggests that exposure to cooler temperatures may increase energy expenditure, offering a novel approach to managing obesity by potentially enhancing calorie burn without altering diet or physical activity.210111213

Research Team

KY

Kong Y Chen, Ph.D.

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

Generally healthy
I am a woman aged between 18 and 35.
Self-reported non-Hispanic and non-Latino Caucasian and African-Americans
See 2 more

Exclusion Criteria

Weight change >5% in the past 6 months or a trained athlete
Iron deficiency (Ferritin < 30 mcg/L males, < 15 mcg/L females)
History of illicit drug or alcohol abuse within the last 5 years; current use of drugs or alcohol
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Inpatient Stay

Participants stay in the Metabolic Unit for up to 14 days to study energy expenditure responses to different temperatures

Up to 14 days
Daily monitoring (inpatient)

Temperature Exposure

Participants are exposed to different temperatures to measure energy expenditure, body temperature, and brown fat activity

7-13 days
Daily monitoring (inpatient)

Follow-up

Participants are monitored for any delayed effects after the inpatient stay

1-2 weeks

Treatment Details

Interventions

  • Room temperatures
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
2,513
Recruited
4,366,000+

Findings from Research

The thermic effect of food, which is the increase in energy expenditure after eating, increases linearly with caloric intake, regardless of whether the individual is lean or obese.
Both lean and obese males showed similar postprandial energy expenditures when consuming the same caloric amounts, indicating that individual thermic responses to food are consistent and not influenced by body composition.
Thermic effect of food in lean and obese men.D'Alessio, DA., Kavle, EC., Mozzoli, MA., et al.[2018]
Obese individuals have a higher total energy expenditure and basal metabolic rate compared to lean individuals, due to increased fat-free mass, which means they burn more calories even at rest.
After losing weight through a hypocaloric diet, obese individuals experience a decrease in total energy expenditure, which can lead to weight regain if their caloric intake is not adjusted accordingly.
Energy metabolism in human obesity.Jéquier, E.[2019]
In a study of 39 overweight women, the hand-held indirect calorimeter provided significantly different estimates of resting energy expenditure (REE) and total energy expenditure (TEE) compared to standardized prediction equations, indicating a lack of agreement between the two methods.
Less than 50% of the prediction equation values were within 10% of the calorimeter measurements, suggesting that these equations may not be reliable for accurately estimating energy needs in this population.
Hand-held indirect calorimeter offers advantages compared with prediction equations, in a group of overweight women, to determine resting energy expenditures and estimated total energy expenditures during research screening.Spears, KE., Kim, H., Behall, KM., et al.[2009]

References

Thermic effect of food in lean and obese men. [2018]
Energy metabolism in human obesity. [2019]
Hand-held indirect calorimeter offers advantages compared with prediction equations, in a group of overweight women, to determine resting energy expenditures and estimated total energy expenditures during research screening. [2009]
Diet-induced thermogenesis: fake friend or foe? [2019]
Reliability of the measurement of postprandial thermogenesis in men of three levels of body fatness. [2019]
Measurement and characterization of energy expenditure as a tool in the development of drugs for metabolic diseases, such as obesity and diabetes. [2016]
Characterization of energy expenditure in rodents by indirect calorimetry. [2016]
The thermic effect of food is reduced in older adults. [2021]
Quantification of the Capacity for Cold-Induced Thermogenesis in Young Men With and Without Obesity. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Effect of moderate cold exposure on 24-h energy expenditure: similar response in postobese and nonobese women. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Energy metabolism in women during short exposure to the thermoneutral zone. [2022]
Postprandial resting metabolic rate and body composition in the moderately obese and normal-weight adult subjects at sitting posture. [2019]
Obesity, diet and body temperature. [2018]