- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02386891
Influence of Ambient Temperature on Food Intake Through a Randomized Control Trial in an Office Setting
11 de março de 2015 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-0022
- University of Alabama at Birmingham School of Public Health
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
19 anos a 35 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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.
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Experimental: Warm
The warm treatment was 25-27°C (77-80.6°F),
which is above the range of the thermalneutral zone.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Food intake (kcalories)
Prazo: 1 hour
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Participants experienced the thermal environment for 1 hour and then were presented food (pizza) and had 1 hour to eat to their fill.
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1 hour
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Estimate of thermoregulation
Prazo: 2 hours
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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.
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2 hours
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2014
Conclusão Primária (Real)
1 de maio de 2014
Conclusão do estudo (Real)
1 de maio de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
6 de março de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de março de 2015
Primeira postagem (Estimativa)
12 de março de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
12 de março de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de março de 2015
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- X140206006
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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