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Clinical Trials/NCT03861208
NCT03861208
Completed
Not Applicable

Assessing if Feelings of Hunger and Fullness Affect Learning in Children 3-4 Years Old

University of Virginia1 site in 1 country22 target enrollmentJuly 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hunger
Sponsor
University of Virginia
Enrollment
22
Locations
1
Primary Endpoint
salivary ghrelin levels
Status
Completed
Last Updated
last year

Overview

Brief Summary

This prospective random controlled cross-over intervention studies is designed to ascertain if children feel different levels of hunger and fullness before and after eating test meals consisting of high-satiety vs. usual foods and if the child's perceived hunger/fullness is related to their salivary ghrelin levels and a variety of learning outcomes. Data are collected at the Diet and Nutrition (DAN) laboratory on repeated study days (8am - 4 pm).

Detailed Description

The investigator's previous research has shown that preschoolers recognized changes in the feelings of hunger/fullness before and after a single test meal. If preschooler's feelings of hunger are associated with their ghrelin (hunger hormone) levels is not known. This study is designed to assess children's changes in feelings of hunger throughout the day (8 pm to 4 pm) and to measure both subjective feelings of hunger and salivary ghrelin levels before and after a standardized test meal (lunch). An important secondary outcome related to children's feelings of hunger is their ability to learn. Currently, there is lack of data on the direct link between perceived hunger/fullness and learning processes. This study addresses these gaps using preschooler's perceived feelings of hunger and fullness (using a published 4-point scale (Kranz S.et al. "High-Protein and High-Dietary-Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast" J Nutr doi: 10.3945/jn.116.234153, 2017) and a battery of learning tests (HTKS, KRISP, Stroop-style tasks, Woodcock Johnson vocabulary test, DCCS, and curisoty measures.)

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
May 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sibylle Kranz, PhD, RDN

Associate Professor

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • healthy children

Exclusion Criteria

  • no food allergies
  • no medications that affect behavior/learning/appetite

Outcomes

Primary Outcomes

salivary ghrelin levels

Time Frame: change in salivary ghrelin from pre-lunch to 2-hours post lunch

change in salivary ghrelin levels will be measured

hunger/fullness 120 minutes postprandial using "children's hunger scale"

Time Frame: change on hunger/fullness scale from pre-lunch to 2-hours post lunch

hunger/fullness scale. change in children's perceived hunger and fullness on an age-appropriate scale: children respond to the question of "are you hungry or full" (coded hungry (1 or 2) or full (3 or 4)) followed by "are you very hungry( or full) or just a little hungry (or full)" coded as 1=very hungry, 2=a little hungry, 3- a little full, 4=very full, thus leading to a 4-point likert scale (from 1 to 4 with 1 being "very hungry" and 4 being "very full"). The development of the scale and its use are published by Kranz S. et al, Journal of Nutrition, 2017.

Secondary Outcomes

  • learning (working memory)(change from pre-lunch to 2-hours post lunch)
  • liking of food(through study completion, on average of 8 weeks)
  • physical activity level(through study completion, on average of 8 weeks)
  • systolic and diastolic blood pressure(through study completion, on average of 8 weeks)
  • anthropometric data(at baseline)

Study Sites (1)

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