Recruiting

Protein Requirements

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT04573439

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 8 - 10

Healthy Volunteers: Accepted

Interventions

Dietary Supplement: Dietary supplement: Protein intake

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT04573439

Start date

Aug 16, 2021

Status verified date

Dec, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 10

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Inclusion Criteria

  • Boys or girls
  • Ages 8-10 years
  • All races
  • All ethnicities
  • Children who were determined to have normal weight (BMI <85th percentile) already determined under Mitochondria (MI) Energy (IRB Protocol: 260376)
  • Participants willing to stop taking nutritional supplements (e.g., multivitamins, vitamin D, fish oil, probiotics, prebiotics, immune boosters, and others) for at least 2 weeks prior to each study testing visit
  • Children without an infection requiring antibiotics willing to be rescheduled after at least 2 months of finalizing antibiotic treatment.
  • Children without viral infections such as diarrhea, cold, or flu willing to be rescheduled after at least 2 weeks of resolution of symptoms.
  • Children determined sedentary or active, based on both peak oxygen uptake (VO2) and accelerometer data, as described below: Children who completed a peak fitness test during MI Energy (IRB Protocol: 260376), and for whom peak VO2 data are as follows:

Peak ⩒O2, ml·min-1·fat free mass index (FFMI)-1 Boys Girls Boys Girls

  • 89 ≤ 80 ≥115 ≥105 FFMI, fat-free mass index

AND

Children who completed accelerometer measures during MI Energy (IRB Protocol: 260376), and for whom average daily activity counts and/or minutes of moderate to vigorous physical activity are as follow:

Sedentary Active Activity counts/day <2,924,494 ≥3,767,075 Minutes of Moderate to vigorous physical activity/day <60 ≥60

Children who completed National Survey of Children's Health and Youth Risk Behavior Survey (NSCH-YRBS) questionnaire during MI Energy study (IRB Protocol: 260376). Children who report ≥3 hours/day of Television (TV) (Sedentary) or ≤2 hours/day of TV (Active) will be considered

  • Children who completed Dual-energy x-ray absorptiometry (DXA) measures during MI Energy study (IRB Protocol: 260376)
  • Children whose parents consented to the following in the MI Energy study (IRB Protocol: 260376): o A) be contacted about future follow-up studies to MI Energy, and having the data that is collected about their child in MI Energy being used also in these follow-up studies; and

  • B) information collected in the MI Energy study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development; and
  • C) any biological samples collected in the MI Energy study may be used in future research related to bioenergetics (for example, blood cell mitochondria function), nutrition, obesity, cardiovascular health, or development.

Exclusion Criteria:

  • • Participants who have been excluded from participation in the study MI Energy (IRB Protocol: 260376)

  • Participants whose parents report any change in medical history that may potentially affect participation and/or study outcomes as determined by PI
  • Weight loss >3 kg in last 6 months
  • Taking medications that knowingly influences protein metabolism
  • Phenylketonuria

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • 13C Phenylalanine Oxidation [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Locations

Arkansas Children's Nutrition Center

Recruiting

Little Rock, Arkansas, United States, 72203

Contacts

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2025-12-30.