Hunger and Learning Study in Preschoolers

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03861208
• Other study ID #: SBS 2018007700
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 23, 2024

Study information

• Verified date: September 2023
• Source: University of Virginia
• Contact: Lori Elder
• Phone: (434) 924-8570
• Email: LJE5U[@]hscmail.mcc.virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 23, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

Inclusion Criteria:

• healthy children

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Food Preferences
• Hunger
• Ingestive Behavior
• Obesity

Intervention

Other:
• diet
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 usually provided foods at childcare are offered

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hunger/fullness 120 minutes postprandial using "children's hunger scale"	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.	change on hunger/fullness scale from pre-lunch to 2-hours post lunch
Primary	salivary ghrelin levels	change in salivary ghrelin levels will be measured	change in salivary ghrelin from pre-lunch to 2-hours post lunch
Secondary	learning (working memory)	Head Toes Knee and Shoulders test	change from pre-lunch to 2-hours post lunch
Secondary	physical activity level	children will wear accelerators while at the laboratory ( 8 pm to 4 pm) to calculate average activity level across the 4 study days	through study completion, on average of 8 weeks
Secondary	liking of food	children will rate the foods provided using an age-appropriate visual (smiley faces) response coded as "like"(smiling face), "neutral" (face with straight line as mouth(, and "don't like" (face with tongue sticking out).	through study completion, on average of 8 weeks
Secondary	anthropometric data	measured height and weight to calculate CDC BMI-for-age percentiles of body weight status	at baseline
Secondary	systolic and diastolic blood pressure	measured systolic and diastolic blood pressure	through study completion, on average of 8 weeks