Clinical trial NCT03861208: Hunger and Learning Study in Preschoolers
Official title: Assessing if Feelings of Hunger and Fullness Affect Learning in Children 3-4 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hunger
Ingestive Behavior
Obesity
Food Preferences
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.)

Eligibility criteria: Inclusion Criteria:

* healthy children

Exclusion Criteria:

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

Primary outcomes:
measure: hunger/fullness 120 minutes postprandial using "children's hunger scale"
timeFrame: change on hunger/fullness scale from pre-lunch to 2-hours post lunch
measure: salivary ghrelin levels
timeFrame: change in salivary ghrelin from pre-lunch to 2-hours post lunch
Secondary outcomes:
measure: learning (working memory)
timeFrame: change from pre-lunch to 2-hours post lunch
measure: physical activity level
timeFrame: through study completion, on average of 8 weeks
measure: liking of food
timeFrame: through study completion, on average of 8 weeks
measure: anthropometric data
timeFrame: at baseline
measure: systolic and diastolic blood pressure
timeFrame: through study completion, on average of 8 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Sibylle Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kranz S, Brauchla M, Campbell WW, Mattes RD, Schwichtenberg AJ. 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. 2017 Mar;147(3):445-452. doi: 10.3945/jn.116.234153. Epub 2017 Jan 11.
citation: Kranz S, Marshall YW, Wight A, Bordi PL, Kris-Etherton PM. Liking and consumption of high-fiber snacks in preschool-age children. Food Quality and Preference 22: 486-489, 2011.