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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06882252
Enrollment
20
Registered
2025-03-18
Start date
2025-02-08
Completion date
2025-12-31
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet Modification

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.

Interventions

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

Sponsors

Sibylle Kranz, PhD, RDN
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glycemic load of diet6 study daysEstimated 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.
Hunger/Satiety self-reported on 4-point scale6 study daysSelf-reported feelings of hunger or fullness using: 1 = Very hungry, 2 = A little hungry, 3 = A little full, 4 = Very full

Secondary

MeasureTime frameDescription
Executive function: focus and short-term memory6 study daysUsing the track-it game, children respond to visual cues.
Executive function: memory and focus6 study daysUsing KRISP, children respond to visual cues to assess focus and short-term memory
Blood pressure60 minutes after the meal.Measured blood pressure 60 minutes after the meal.
Executive Function: Concentration6 study daysUsing 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.
Executive Function: Focus and Concentration6 study daysUsing 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.
Blood glucose6 study daysBlood glucose concentration 60 minutes after the meal. Measured using finger-stick and glucometer reading.

Countries

United States

Contacts

Primary ContactSibylle Kranz, PhD, RD
sibylle.kranz@virginia.edu434-924-7904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026