Recruiting

Lean Protein

Sponsor:

Sibylle Kranz, PhD, RDN

Code:

NCT06882252

Conditions

Diet Modification

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

Interventions

Low glycemic index diet

Study Details

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

Study ID

NCT06882252

Start date

Feb 8, 2025

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 5

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Intervention

Diet modification: Low glycemic index diet Meal and snack are made with lean pork to reduce glycemic index of food consumed.

no intervention: Control

Typically consumed meal and snack; high glycemic index

Interventions

Low glycemic index diet

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

Primary outcome measure

  • Glycemic load of diet [ Time Frame: 6 study days ]
  • Hunger/Satiety self-reported on 4-point scale [ Time Frame: 6 study days ]

Central Contacts and Locations

Central contacts

Sibylle Kranz, PhD, RD

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

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Sibylle Kranz, PhD, RD

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

More Information

Sponsor

Sibylle Kranz, PhD, RDN

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sibylle Kranz, PhD, RDN on 2025-03-18.