- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02759523
Neural Mechanisms Underlying Children's Responses to Food Portion Size and Energy Density
Increased portion sizes of foods high in energy density (calories per gram of food) have been implicated in the obesity epidemic. Numerous studies show that children and adults eat more from larger portions of food than they do from smaller portions, a response known as the portion size effect. Despite the robust and consistent nature of these findings, the mechanisms underlying the portion size effect are not known. The long-term goal of this research is to identify the neural mechanisms involved in the portion size effect so that this information can be used to develop effective weight-management strategies. Differences in neural response to food cues, as demonstrated by functional magnetic resonance imaging (fMRI), can help clarify the factors that determine susceptibility to large portions. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.
The investigators hypothesize that high relative to low energy density food images will be associated with increased activation in regions of the brain involved in reward- and sensory- processing and that large relative to small portion size food images will be associated with increased activation in regions of the brain involved in cognitive control. In addition, the investigators hypothesize that these brain responses will influence the relationship between portion size served and energy intake at laboratory meals.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Right-handedness
- English as native language
- Reading at /above grade level
- Not claustrophobic
- Generally healthy
Exclusion Criteria:
- Left-handedness
- Metal in or on the body that cannot be removed
- Claustrophobic
- Medication usage that could alter brain activity
- Medical disorder that may impact comfort in scanner
- Food allergies
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
fMRI blood oxygen level dependent (BOLD) response to food portion size and energy density
Prazo: Collected at fMRI scan (1 of 1) at week 5
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Whole-brain response to food images that varied at 2 levels of portion size and 2 levels of energy density
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Collected at fMRI scan (1 of 1) at week 5
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Energy intake
Prazo: Collected at week 1, 2, 3, and 4
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Energy intake (kcal and grams) of foods consumed ad libitum at each laboratory test-meal in response to 4 conditions of portion sizes (100% reference, 133%, 167%, 200%).
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Collected at week 1, 2, 3, and 4
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Region of Interest (ROI)-response to food portion size and energy density
Prazo: Collected at fMRI scan (1 of 1) at week 5
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Response in selected brain regions of interest to food images varied at 2 levels of portion size and 2 levels of energy density
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Collected at fMRI scan (1 of 1) at week 5
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Appetitive traits
Prazo: Collected at week 1 (Baseline)
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Parent-reported questionnaire of habitual eating styles in children
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Collected at week 1 (Baseline)
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Body composition a/o weight status
Prazo: Collected at week 1 (Baseline)
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Height, weight and body fat percentage were measured.
Body mass index (BMI), BMI z score, fat-mass index and fat-free-mass index will be calculated.
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Collected at week 1 (Baseline)
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Liking of foods
Prazo: Collected at week 5
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Ratings of how much child likes food presented on a computerized visual analog scale
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Collected at week 5
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Wanting of foods
Prazo: Collected at week 5
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Ratings of how much child wants food presented on a computerized visual analog scale
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Collected at week 5
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Loss of control eating
Prazo: Collected at week 1 (Baseline)
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Loss of control when eating is frequently reported in middle childhood.
Loss of control when eating was assessed via interview-style questionnaire to determine pre-clinical binge-like eating behaviors that may influence the primary outcome of energy intake at the 4 conditions of test-meals.
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Collected at week 1 (Baseline)
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Parental feeding strategies
Prazo: Collected at week 1 (Baseline)
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Parent-reported measures of feeding practices
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Collected at week 1 (Baseline)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kathleen Keller, PhD, The Pennsylvania State University
Publicações e links úteis
Publicações Gerais
- English L, Lasschuijt M, Keller KL. Mechanisms of the portion size effect. What is known and where do we go from here? Appetite. 2015 May;88:39-49. doi: 10.1016/j.appet.2014.11.004. Epub 2014 Nov 11.
- Fearnbach SN, English LK, Lasschuijt M, Wilson SJ, Savage JS, Fisher JO, Rolls BJ, Keller KL. Brain response to images of food varying in energy density is associated with body composition in 7- to 10-year-old children: Results of an exploratory study. Physiol Behav. 2016 Aug 1;162:3-9. doi: 10.1016/j.physbeh.2016.03.007. Epub 2016 Mar 10.
- Diktas HE, Keller KL, Roe LS, Rolls BJ. Children's Portion Selection Is Predicted by Food Liking and Is Related to Intake in Response to Increased Portions. J Nutr. 2022 Oct 6;152(10):2287-2296. doi: 10.1093/jn/nxac162.
- Keller KL, English LK, Fearnbach SN, Lasschuijt M, Anderson K, Bermudez M, Fisher JO, Rolls BJ, Wilson SJ. Brain response to food cues varying in portion size is associated with individual differences in the portion size effect in children. Appetite. 2018 Jun 1;125:139-151. doi: 10.1016/j.appet.2018.01.027. Epub 2018 Feb 2.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FoodBehavior01
Plano para dados de participantes individuais (IPD)
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