Food Intake in 2 Thermal EnvironmentsNCT02386891
Influence of Ambient Temperature on Food Intake Through a Randomized Control Trial in an Office Setting
A study testing Thermal Environment in people with Food Intake in 2 Thermal Environments, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Based on preliminary data and previous studies, the investigators hypothesize that the ambient temperature experienced by an individual influences his or her food intake in males and females aged 19 to 30. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Intake in 2 Thermal Environments
- What is being tested?
- Thermal Environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 2014
- Phase
- Interventional
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 19-35
- Men and women
Who cannot join
- Any food allergy, including, but not limited to lactose or gluten intolerance.
- Religious affiliations that include specific food guidelines.
- Personal dietary restrictions, including but not limited to veganism.
- Participation in any weight-reduction program, weight-loss diet, or other special diet within the previous 3 months.
- Weight loss or gain of >5% of body weight in the past 6 months for any reason except post-partum weight loss.
- Currently taking medication that suppresses or stimulates appetite or that affects body weight, including oral anti-diabetic medications.
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- History of prior surgical procedure for weight control or liposuction.
- Anyone currently taking statins.
- Self report of high blood pressure (above 140 systolic, 90 diastolic)
- Current smoker or quit smoking less than 6 months prior.
- Any major disease, including:
- Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
- Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
- Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
- Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- Active renal disease.
- Lung disease: chronic obstructive airway disease requiring use of oxygen.
- Diagnosed diabetes (type 1 or 2).
- Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
- Self reported history of or current eating disorders
- Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent staff; another household member is a participant or staff member in the trial; current or anticipated participation in another research project that would interfere with the offered session; unwilling to accept condition assignment by randomization
- Currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months.
- Self-report of a recent or ongoing problem with drug abuse or addiction.
- Self report of excessive alcohol intake, either acute or chronic, defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months
- Pregnancy and childbearing: currently pregnant or less than 3 months post partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during between time of screening and session date; unwilling to report possible or confirmed pregnancies promptly during the course of the trial;
- Students in the Environmental Health Science Department, Nutrition Sciences School, Any student, trainee, or post-doctoral fellow who is directly or indirectly receiving funding from the Nutrition Obesity Research Center.
- Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham School of Public Health
Birmingham, Alabama, 35294-0022
About this study
Based on preliminary data and previous studies, the investigators hypothesize that the ambient temperature experienced by an individual influences his or her food intake in males and females aged 19 to 30. Specifically, exposure to temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in a sedentary situation. Researchers will execute a randomized control trial specifically testing thermal exposure and its effect on an individual's food consumption. Participants will receive and wear a t-shirt. They will have a thermal image taken of the inner canthus of their eye and middle finger nail bed, representing a baseline of core and peripheral temperatures, respectively. They will be randomized to either a colder environment (65°F) or a warmer environment (75°F) under the artifice of monitoring routine office work with abnormal temperature conditions. Their knowledge of the experiment will be limited until the end. They will experience this temperature while filling out paperwork and performing basic office tasks. After one hour, another thermal image will be taken. Each participant will be presented with a large, Mellow Mushroom cheese pizza and directed to eat at their leisure and subsequently finish the office tasks over the next hour. The participants will then be debriefed on the parameters of the experiment and body measurements will be taken at the end so as to prevent bias of the subject by limiting their food intake. The investigators will quantify energy intake by weighing remaining food and comparing to known caloric content by weight from bomb calorimetry tests. The infrared thermal images will determine whether the temperatures experienced were extreme enough to initiate a change in thermoregulation.
Read the detailed description
Previous studies suggest increased time spent outdoors is associated with lower body mass index (BMI).1,2 . In addition, energy expenditure and hunger have been associated with exposure to heat or cold. Increased usage of central heating and air conditioning systems coupled with increased time spent indoors has created an environment where humans are expending less energy to regulate their body temperature.3 The human thermoneutral zone (TNZ) is the range of ambient temperatures in which a healthy adult can maintain body temperature without expending energy beyond the normal basal metabolic rate. Energy intake and expenditure are adjusted at temperatures above and below the TNZ.4 The temperature of the food, smell, time of consumption, and number of people present are established factors that influence food consumption in humans.5 In addition, evidence supports the role of the environment upon an individual's food intake. Wall color, lighting, and ambient noise, influence consumption preferences and quantities.6 Based on research in animal models, particularly mice and livestock,food intake and subsequently, weight gain is reduced in high ambient temperatures.7-10 In addition in young, physically active, healthy males, food intake is inversely proportional to TNZ.11 However, energy expenditure increases above and below the TNZ. These studies are based on extreme conditions, therefore there is a lack of information on how small changes in ambient temperature may affect food intake in the general human public. Recent research shows the effectiveness of small changes over time to lead to changes in consumption practices.12 Thus, altering the thermal environment subtly may lead to a greater understanding of long term effects in weight management. The investigators have previously examined the thermal environment of persons going about their daily lives in both urban and rural settings (X120217008). Preliminary analysis of the results suggest increased % body fat is associated with lower heat exposure.
- Conditions
- Food Intake in 2 Thermal Environments
- Being tested
- Thermal Environment
- Keywords
- food intake, indoor thermal environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal EnvironmentOther
| Study group | Role | What they receive |
|---|---|---|
| Cold | Experimental | The cold treatment was 18-20°C (64.5-68°F), which is at the lower end of the thermalneutral zone in healthy adults. Receives: Other: Thermal Environment |
| Warm | Experimental | The warm treatment was 25-27°C (77-80.6°F), which is above the range of the thermalneutral zone. Receives: Other: Thermal Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake (kcalories)
Participants experienced the thermal environment for 1 hour and then were presented food (pizza) and had 1 hour to eat to their fill.
Measured: 1 hour
Secondary outcomes (1)
Estimate of thermoregulation
An infrared thermal camera took thermal images of partipants inner canthus and 3rd fingernail bed as estimates of core and peripheral temperature respectively. The difference between core minus peripheral temperature estimates whether heat dissipation has been initiated.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food Intake in 2 Thermal EnvironmentsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386891
- Sponsor's protocol ID
- X140206006
- Status last verified
- Mar 2015
- First submitted
- 6 Mar 2015
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernhard MC, Li P, Allison DB, Gohlke JM. Warm Ambient Temperature Decreases Food Intake in a Simulated Office Setting: A Pilot Randomized Controlled Trial. Front Nutr. 2015 Aug 24;2:20. doi: 10.3389/fnut.2015.00020. eCollection 2015.
PubMed 26322311
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ambient Temperature on Food Intake Through a Randomized Control Trial in an Office Setting
- ClinicalTrials.gov ID
- NCT02386891
- Acronym / sponsor ID
- X140206006
- Conditions
- Food Intake in 2 Thermal Environments
- Keywords
- food intake, indoor thermal environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Mar 2015 (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.
Based on preliminary data and previous studies, the investigators hypothesize that the ambient temperature experienced by an individual influences his or her food intake in males and females aged 19 to 30. Specifically, exposure to temperatures above the thermoneutral zone (TNZ) will decrease consumption in young adults in a sedentary situation. Researchers will execute a randomized control trial specifically testing thermal exposure and its effect on an individual's food consumption. Participants will receive and wear a t-shirt. They will have a thermal image taken of the inner canthus of their eye and middle finger nail bed, representing a baseline of core and peripheral temperatures, respectively. They will be randomized to either a colder environment (65°F) or a warmer environment (75°F) under the artifice of monitoring routine office work with abnormal temperature conditions. Their knowledge of the experiment will be limited until the end. They will experience this temperature while filling out paperwork and performing basic office tasks. After one hour, another thermal image will be taken. Each participant will be presented with a large, Mellow Mushroom cheese pizza and directed to eat at their leisure and subsequently finish the office tasks over the next hour. The participants will then be debriefed on the parameters of the experiment and body measurements will be taken at the end so as to prevent bias of the subject by limiting their food intake. The investigators will quantify energy intake by weighing remaining food and comparing to known caloric content by weight from bomb calorimetry tests. The infrared thermal images will determine whether the temperatures experienced were extreme enough to initiate a change in thermoregulation.
Detailed description
Previous studies suggest increased time spent outdoors is associated with lower body mass index (BMI).1,2 . In addition, energy expenditure and hunger have been associated with exposure to heat or cold. Increased usage of central heating and air conditioning systems coupled with increased time spent indoors has created an environment where humans are expending less energy to regulate their body temperature.3 The human thermoneutral zone (TNZ) is the range of ambient temperatures in which a healthy adult can maintain body temperature without expending energy beyond the normal basal metabolic rate. Energy intake and expenditure are adjusted at temperatures above and below the TNZ.4 The temperature of the food, smell, time of consumption, and number of people present are established factors that influence food consumption in humans.5 In addition, evidence supports the role of the environment upon an individual's food intake. Wall color, lighting, and ambient noise, influence consumption preferences and quantities.6 Based on research in animal models, particularly mice and livestock,food intake and subsequently, weight gain is reduced in high ambient temperatures.7-10 In addition in young, physically active, healthy males, food intake is inversely proportional to TNZ.11 However, energy expenditure increases above and below the TNZ. These studies are based on extreme conditions, therefore there is a lack of information on how small changes in ambient temperature may affect food intake in the general human public. Recent research shows the effectiveness of small changes over time to lead to changes in consumption practices.12 Thus, altering the thermal environment subtly may lead to a greater understanding of long term effects in weight management. The investigators have previously examined the thermal environment of persons going about their daily lives in both urban and rural settings (X120217008). Preliminary analysis of the results suggest increased % body fat is associated with lower heat exposure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold | Experimental | Other: Thermal EnvironmentThe cold treatment was 18-20°C (64.5-68°F), which is at the lower end of the thermalneutral zone in healthy adults. |
| Warm | Experimental | Other: Thermal EnvironmentThe warm treatment was 25-27°C (77-80.6°F), which is above the range of the thermalneutral zone. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (27 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal Environment | Other | Cold, Warm |
Primary outcome
Food intake (kcalories)
Time frame: 1 hour
Participants experienced the thermal environment for 1 hour and then were presented food (pizza) and had 1 hour to eat to their fill.
1 secondary outcome
Estimate of thermoregulation
Time frame: 2 hours
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 12 Mar 2015.
- Derived from this study: PubMed 26322311Bernhard MC, Li P, Allison DB, Gohlke JM. Warm Ambient Temperature Decreases Food Intake in a Simulated Office Setting: A Pilot Randomized Controlled Trial. Front Nutr. 2015 Aug 24;2:20. doi: 10.3389/fnut.2015.00020. eCollection 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Environment in people with Food Intake in 2 Thermal Environments, run by University of Alabama at Birmingham 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 2 inclusion and 27 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 12 Mar 2015. 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?
Food intake (kcalories) (time frame: 1 hour). 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 NCT02386891, which also lists 1 linked publication.
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 12 Mar 2015.