Protein Requirements for Active Children

NCT04573439 | Recruiting

• 1 other identifier: 261235
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 13C Phenylalanine Oxidation

  Urine and breath will be collected during the study to measure the rate of 13C phenylalanine oxidation

  8 hours

Interventions

Dietary Supplement: Dietary supplement: Protein intake DIETARY_SUPPLEMENT

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.

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72203, United States

RECRUITING

Study Officials

• Eva C Diaz Fuentes, MD

  Arkansas Children's Nutrition Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonja C Nolen, MS

CONTACT

5013643309; acncstudies@archildrens.org

Audrey Martinez, MS, RD, LD

CONTACT

5013643309; acncstudies@archildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: August 16, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)