Hunger and Learning Study in Preschoolers

NCT03861208 | Completed

• 1 other identifier: SBS 2018007700
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Hunger; Ingestive Behavior; Obesity; Food Preferences

Outcome Measures

Primary Outcomes (2)

• 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

• salivary ghrelin levels

  change in salivary ghrelin levels will be measured

  change in salivary ghrelin from pre-lunch to 2-hours post lunch

Secondary Outcomes (5)

• learning (working memory)

  change from pre-lunch to 2-hours post lunch

• physical activity level

  through study completion, on average of 8 weeks

• liking of food

  through study completion, on average of 8 weeks

• anthropometric data

  at baseline

• systolic and diastolic blood pressure

  through study completion, on average of 8 weeks

Study Arms (2)

diet

EXPERIMENTAL

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

Other: diet

usual diet

OTHER

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

Other: usual diet

Interventions

diet OTHER

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

Also known as: High protein high fiber

diet

usual diet OTHER

foods representing the usually provided foods at childcare are offered

usual diet

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy children

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related 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.

  PMID: 28077732 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Feeding Behavior; Obesity; Food Preferences

Interventions

Diet

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sibylle Kranz, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: March 4, 2019
• Study Start: July 1, 2018
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

US (1)