Influence of Ambient Temperature on Food Intake Through a Randomized Control Trial in an Office Setting

March 11, 2015 updated by: University of Alabama at Birmingham
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0022
        • University of Alabama at Birmingham School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion Criteria:

    • Ages 19-35
    • Men and women

Exclusion Criteria:

  • Exclusion Criteria:

    • 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.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cold
The cold treatment was 18-20°C (64.5-68°F), which is at the lower end of the thermalneutral zone in healthy adults.
Other: Thermal Environment
Experimental: Warm
The warm treatment was 25-27°C (77-80.6°F), which is above the range of the thermalneutral zone.
Other: Thermal Environment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimate of thermoregulation
Time Frame: 2 hours
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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X140206006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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