- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
fMRI blood oxygen level dependent (BOLD) response to food portion size and energy density
Časové okno: Collected at fMRI scan (1 of 1) at week 5
|
Whole-brain response to food images that varied at 2 levels of portion size and 2 levels of energy density
|
Collected at fMRI scan (1 of 1) at week 5
|
Energy intake
Časové okno: Collected at week 1, 2, 3, and 4
|
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%).
|
Collected at week 1, 2, 3, and 4
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Region of Interest (ROI)-response to food portion size and energy density
Časové okno: Collected at fMRI scan (1 of 1) at week 5
|
Response in selected brain regions of interest to food images varied at 2 levels of portion size and 2 levels of energy density
|
Collected at fMRI scan (1 of 1) at week 5
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Appetitive traits
Časové okno: Collected at week 1 (Baseline)
|
Parent-reported questionnaire of habitual eating styles in children
|
Collected at week 1 (Baseline)
|
Body composition a/o weight status
Časové okno: Collected at week 1 (Baseline)
|
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.
|
Collected at week 1 (Baseline)
|
Liking of foods
Časové okno: Collected at week 5
|
Ratings of how much child likes food presented on a computerized visual analog scale
|
Collected at week 5
|
Wanting of foods
Časové okno: Collected at week 5
|
Ratings of how much child wants food presented on a computerized visual analog scale
|
Collected at week 5
|
Loss of control eating
Časové okno: Collected at week 1 (Baseline)
|
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.
|
Collected at week 1 (Baseline)
|
Parental feeding strategies
Časové okno: Collected at week 1 (Baseline)
|
Parent-reported measures of feeding practices
|
Collected at week 1 (Baseline)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Kathleen Keller, PhD, The Pennsylvania State University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- FoodBehavior01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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