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Hunger and Learning Study in Preschoolers

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University of Virginia

Status

Completed

Conditions

Ingestive Behavior
Obesity
Hunger
Food Preferences

Treatments

Other: usual diet
Other: diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03861208
SBS 2018007700

Details and patient eligibility

About

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).

Full 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.)

Enrollment

22 patients

Sex

All

Ages

3 to 4 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy children

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

22 participants in 2 patient groups

diet
Experimental group
Description:
high fiber high protein foods served in childcare centers are offered for meals and snacks
Treatment:
Other: diet
usual diet
Other group
Description:
foods representing the usual diet in childcare centers are offered for meals and snacks
Treatment:
Other: usual diet

Trial contacts and locations

1

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Central trial contact

Lori Elder; Sibylle Kranz

Data sourced from clinicaltrials.gov

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