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

2015年3月11日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alabama
      • Birmingham、Alabama、美国、35294-0022
        • University of Alabama at Birmingham School of Public Health

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 至 35年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
实验性的:Warm
The warm treatment was 25-27°C (77-80.6°F), which is above the range of the thermalneutral zone.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Food intake (kcalories)
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Estimate of thermoregulation
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年3月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2015年3月6日

首先提交符合 QC 标准的

2015年3月11日

首次发布 (估计)

2015年3月12日

研究记录更新

最后更新发布 (估计)

2015年3月12日

上次提交的符合 QC 标准的更新

2015年3月11日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • X140206006

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Thermal Environment的临床试验

3
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