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NCT Number: NCT06882252

Increasing Lean Protein Intake in Preschool-age Children and Assessing Effects on Cognition and Select Health Outcomes

The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger/satiety based on consuming a snack and a meal (lunch/dinner) that are either based on the usual childcare center fare (control) or are based on lean meats (intervention), which will have a lower glycemic index.

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Key information

Conditions

Diet Modification

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location status: Recruiting

Location contact

Sibylle Kranz, PhD, RD

CONTACT

[email protected]

434-924-7904

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • child 2-5 years old

Parent participants:

  • Parents of at least one child aged 2-5 years old
  • Parents can communicate in English.
  • Parents in households who do not have a cultural/ religious reason to abstain from to consuming pork

Exclusion criteria

  • Child participants:
  • Food allergies
  • Taking medication that affects food intake (such as stimulant medications),
  • Children with diabetes or impaired glucose control.
  • Children with digestive disease (such as Crohn's)
  • Dietary/religious preferences that exclude consumption of pork

Parent participants:

  • Dietary/religious preferences that exclude consumption of pork

Treatment and study plan

Low glycemic index diet

Other

Replacement of typical meal/snack with lean pork containing meal/snack

Primary outcomes

  1. Glycemic load of diet

    Time frame: 6 study days

    Estimated intake of glycemic load of meals and snacks consumed. Plate-waste method will be used to calculate total energy, GI, GL consumed at each meal and snack using disaggregated intake (in grams) and analysis using Nutrient Data System for Research (NDS-R) software.

  2. Hunger/Satiety self-reported on 4-point scale

    Time frame: 6 study days

    Self-reported feelings of hunger or fullness using: 1 = Very hungry, 2 = A little hungry, 3 = A little full, 4 = Very full

Secondary outcomes

  1. Blood pressure

    Time frame: 60 minutes after the meal.

    Measured blood pressure 60 minutes after the meal.

  2. Blood glucose

    Time frame: 6 study days

    Blood glucose concentration 60 minutes after the meal. Measured using finger-stick and glucometer reading.

  3. Executive function: focus and short-term memory

    Time frame: 6 study days

    Using the "track-it" game, children respond to visual cues.

  4. Executive function: memory and focus

    Time frame: 6 study days

    Using KRISP, children respond to visual cues to assess focus and short-term memory

  5. Executive Function: Focus and Concentration

    Time frame: 6 study days

    Using the "peg it" game, children are asked to use a small wooden hammer to tab the table surface. First, they repeat how many tabs the researcher demonstrated (1 or 2), then they are asked to tab the opposite, so if the researcher tabs once, they tab twice and when the researcher tabs twice, they tab once.

  6. Executive Function: Concentration

    Time frame: 6 study days

    Using the happy-sad game, children sort small playing cards with happy or sad faces on them to align with the verbal cue of the researcher, or to put down the opposite card.

Study contacts

Contact information is provided by the study sponsor or research team.

Sibylle Kranz, PhD, RD

CONTACT

[email protected]

434-924-7904

Sponsors and collaborators

Lead sponsor

Sibylle Kranz, PhD, RDN

Other

Registry information

Official study title

Increasing Lean Protein Intake in Preschool-age Children

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

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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