NCT04573439

Protein Requirements for Active Children

Children's Protein Requirements With Physical Activity: The ChiPP Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: All
• Age: 8 Years – 10 Years
• Healthy volunteers: Accepted

Summary

There is reason to believe the current dietary reference intakes for dietary protein for children are too low. Furthermore, children with high levels of physical activity and fitness may require a higher requirement. To better understand the protein requirements in minimally and highly physically fit and active children 8-10 y old, investigators will use the indicator amino acid oxidation technique.

Detailed description

Purpose: Determine dietary protein requirements using the indicator amino acid oxidation (IAAO) method in a group of thoroughly phenotyped school-age children who engage in different levels of Physical Activity. Hypothesis: Daily dietary protein requirements are greater in children with high level of physical activity vs. sedentary children. Justification: Adequate dietary protein intake is essential to support cellular integrity, physical growth and function. Although dietary protein malnutrition is not prevalent in the U.S., highly active individuals may require greater than the average protein intake to support both increased metabolic demands and skeletal muscle repair and remodeling. The current Institute of Medicine (IOM) guidelines do not have separate dietary protein estimated average requirement (EARs) for physically active children. Research Design: This is a comparative two-group (sedentary vs. physically active), single center, prospective cohort study designed to estimate and compare the dietary protein requirements among sedentary and active children between the ages of 8-10 years. Each participant will be assigned to 7 one-day dietary protein levels with the goal of obtaining measures of phenylalanine oxidation corresponding to each level of protein intake. Up to 30 children will be recruited for this study at the Arkansas Children's Nutrition Center (ACNC) with the expectation of a 20% attrition rate resulting in a total of 24 children (n=12/group) in the final analysis. The recruitment will ensure equal representation of both sexes of children. After screening, the children and parents will attend an in-person or remote assent/consent visit. After the assent/consent visit, children will consume a 2-day run-in diet to ensure protein intakes of 1.5 g/kg/day and energy intakes of 1.7 x resting energy expenditure. Each child will participate in 7 testing days, following an overnight fast before each visit. At each of these testing days, participants will be randomly assigned to one of 7 test protein dosages (0.2-2.4 g·kg-1·d-1) consisting of 8 isocaloric and isonitrogenous meals provided hourly, each meal presenting 1/12 of the daily energy requirement. Study day diet is composed of a crystalline amino acid mixture based on the amino acid profile of egg protein and protein free diet toddler and 2 formulas for carbohydrate and fat. A stable isotope tracer will be added to the 5th through 8th meals. Investigators will measure the rate of oxidation of this tracer expired in breath (F13CO2), and flux of this tracer by its enrichment in urine.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary Supplement: Dietary supplement: Protein intake	Oral consumption of hourly experimental meals. Includes 4 meals containing a mixture of free amino acids, carbohydrates and fats from a protein-free formula mixture. The last 4 meals will contain labelled 13C phenylalanine.

Timeline

• Start date: 2021-08-16
• Primary completion: 2026-06-30
• Completion: 2026-07-01
• First posted: 2020-10-05
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States