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

NCT06882252 | Recruiting

• 1 other identifier: HSR231601
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Blood pressure

  60 minutes after the meal.

• Blood glucose

  6 study days

• Executive function: focus and short-term memory

  6 study days

• Executive function: memory and focus

  6 study days

• Executive Function: Focus and Concentration

  6 study days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Typically consumed meal and snack; high glycemic index

Interventions

Low glycemic index diet OTHER

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

Intervention

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sibylle Kranz, PhD, RDN: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 36029824 BACKGROUND

• 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.

  PMID: 16022763 BACKGROUND

Central Study Contacts

Sibylle Kranz, PhD, RD

CONTACT

434-924-7904; sibylle.kranz@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 18, 2025
• Study Start: February 8, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)