Clinical Trials Directory

Trials / Completed

CompletedNCT03861208

Hunger and Learning Study in Preschoolers

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
University of Virginia · Academic / Other
Sex
All
Age
3 Years – 4 Years
Healthy volunteers
Accepted

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.)

Conditions

Interventions

TypeNameDescription
OTHERdietfoods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial
OTHERusual dietfoods representing the usually provided foods at childcare are offered

Timeline

Start date
2018-07-01
Primary completion
2024-05-15
Completion
2024-05-15
First posted
2019-03-04
Last updated
2024-06-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03861208. Inclusion in this directory is not an endorsement.