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NCT Number: NCT03861208

Hunger and Learning Study in Preschoolers

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).

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Key information

Conditions

Hunger Behavior Behavior, Animal Body Weight Feeding Behavior Food Preferences Ingestive Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22904, United States

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy children

Exclusion criteria

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

Treatment and study plan

Diet

Other

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

Other names: High protein high fiber

Usual diet

Other

foods representing the usually provided foods at childcare are offered

Primary outcomes

  1. hunger/fullness 120 minutes postprandial using "children's hunger scale"

    Time frame: change on hunger/fullness scale from pre-lunch to 2-hours post lunch

    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.

  2. salivary ghrelin levels

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

    change in salivary ghrelin levels will be measured

Secondary outcomes

  1. learning (working memory)

    Time frame: change from pre-lunch to 2-hours post lunch

    Head Toes Knee and Shoulders test

  2. physical activity level

    Time frame: through study completion, on average of 8 weeks

    children will wear accelerators while at the laboratory ( 8 pm to 4 pm) to calculate average activity level across the 4 study days

  3. liking of food

    Time frame: through study completion, on average of 8 weeks

    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).

  4. anthropometric data

    Time frame: at baseline

    measured height and weight to calculate CDC BMI-for-age percentiles of body weight status

  5. systolic and diastolic blood pressure

    Time frame: through study completion, on average of 8 weeks

    measured systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2019
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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