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

Increasing Lean Protein Intake in Preschool-age Children

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.

Study Overview

• Status: Recruiting
• Conditions: Diet Modification
• Intervention / Treatment: Other: Low glycemic index diet

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sibylle Kranz, PhD, RD; Phone Number: 434-924-7904; Email: sibylle.kranz@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Sibylle Kranz, PhD, RD; Phone Number: 434-924-7904; Email: sibylle.kranz@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Diet modification: Low glycemic index diet Meal and snack are made with lean pork to reduce glycemic index of food consumed.	Other: Low glycemic index diet; Replacement of typical meal/snack with lean pork containing meal/snack
No Intervention: Control; Typically consumed meal and snack; high glycemic index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic load of diet	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.	6 study days
Hunger/Satiety self-reported on 4-point scale	Self-reported feelings of hunger or fullness using: 1 = Very hungry, 2 = A little hungry, 3 = A little full, 4 = Very full	6 study days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Measured blood pressure 60 minutes after the meal.	60 minutes after the meal.
Blood glucose	Blood glucose concentration 60 minutes after the meal. Measured using finger-stick and glucometer reading.	6 study days
Executive function: focus and short-term memory	Using the "track-it" game, children respond to visual cues.	6 study days
Executive function: memory and focus	Using KRISP, children respond to visual cues to assess focus and short-term memory	6 study days
Executive Function: Focus and Concentration	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 study days
Executive Function: Concentration	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.	6 study days

Collaborators and Investigators

• Sponsor: Sibylle Kranz, PhD, RDN

Publications and helpful links

General Publications

• Varley BJ, Nasir RF, Skilton MR, Craig ME, Gow ML. Early Life Determinants of Vascular Structure in Fetuses, Infants, Children, and Adolescents: A Systematic Review and Meta-Analysis. J Pediatr. 2023 Jan;252:101-110.e9. doi: 10.1016/j.jpeds.2022.08.033. Epub 2022 Aug 24.
• Mikkila V, Rasanen L, Raitakari OT, Pietinen P, Viikari J. Consistent dietary patterns identified from childhood to adulthood: the cardiovascular risk in Young Finns Study. Br J Nutr. 2005 Jun;93(6):923-31. doi: 10.1079/bjn20051418.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HSR231601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small pilot and feasibility study and subjects may be identified if individual participant data is shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No