Hunger and Learning Study in Preschoolers

NCT ID: NCT03861208

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2024-05-15

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.)

Conditions

Hunger; Ingestive Behavior; Obesity; Food Preferences

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

diet

high fiber high protein foods served in childcare centers are offered for meals and snacks

Group Type: EXPERIMENTAL

diet

Intervention Type: OTHER

foods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial

usual diet

foods representing the usual diet in childcare centers are offered for meals and snacks

Group Type: OTHER

usual diet

Intervention Type: OTHER

foods representing the usually provided foods at childcare are offered

Interventions

diet

foods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial

Intervention Type: OTHER

usual diet

foods representing the usually provided foods at childcare are offered

Intervention Type: OTHER

Other Intervention Names

High protein high fiber

Eligibility Criteria

Inclusion Criteria

• healthy children

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Sibylle Kranz, PhD, RDN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sibylle Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28077732 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

SBS 2018007700

Identifier Type: -

Identifier Source: org_study_id