- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI blood oxygen level dependent (BOLD) response to food portion size and energy density
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Region of Interest (ROI)-response to food portion size and energy density
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetitive traits
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Collected at week 1 (Baseline)
|
Parent-reported measures of feeding practices
|
Collected at week 1 (Baseline)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen Keller, PhD, The Pennsylvania State University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FoodBehavior01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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