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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorSibylle Kranz, PhD, RDN

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

child 2-5 years old

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low glycemic index diet

    Other intervention

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 study days
2

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

Time frame
6 study days

Secondary outcomes

1

Blood pressure

Measured blood pressure 60 minutes after the meal.

Time frame
60 minutes after the meal.
2

Blood glucose

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

Time frame
6 study days
3

Executive function: focus and short-term memory

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

Time frame
6 study days
4

Executive function: memory and focus

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

Time frame
6 study days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sibylle Kranz, PhD, RDN

Lead sponsor

University of Virginia

Sponsor institution