- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02386891
Influence of Ambient Temperature on Food Intake Through a Randomized Control Trial in an Office Setting
11 de marzo de 2015 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35294-0022
- University of Alabama at Birmingham School of Public Health
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
19 años a 35 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
|
Experimental: Warm
The warm treatment was 25-27°C (77-80.6°F),
which is above the range of the thermalneutral zone.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Food intake (kcalories)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Estimate of thermoregulation
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2014
Finalización primaria (Actual)
1 de mayo de 2014
Finalización del estudio (Actual)
1 de mayo de 2014
Fechas de registro del estudio
Enviado por primera vez
6 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
11 de marzo de 2015
Publicado por primera vez (Estimar)
12 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de marzo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
11 de marzo de 2015
Última verificación
1 de marzo de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- X140206006
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .