Increasing Lean Protein Intake in Preschool-age Children and Assessing Effects on Cognition and Select Health Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low glycemic index diet.
- Who it may be relevant to
- Registry conditions: Diet Modification. Basic parameters: 2 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Increasing Lean Protein Intake in Preschool-age Children
Overview
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
- Other Low glycemic index diet
Replacement of typical meal/snack with lean pork containing meal/snack
Primary outcome measures
- Glycemic load of diet [Time frame: 6 study days]
- Hunger/Satiety self-reported on 4-point scale [Time frame: 6 study days]
Secondary outcome measures (6)
- Blood pressure [Time frame: 60 minutes after the meal.]
- Blood glucose [Time frame: 6 study days]
- Executive function: focus and short-term memory [Time frame: 6 study days]
- Executive function: memory and focus [Time frame: 6 study days]
- Executive Function: Focus and Concentration [Time frame: 6 study days]
- Executive Function: Concentration [Time frame: 6 study days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Virginia — Charlottesville
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. PMID 36029824
- 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
Identifiers
NCT: NCT06882252 · HSR231601