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Protein Requirements for Active Children (ChiPP)

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ClinicalTrials.gov Identifier: NCT04573439
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : February 5, 2024
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Dietary Supplement: Dietary supplement: Protein intake Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Children's Protein Requirements With Physical Activity: The ChiPP Study
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2025
Arms and Interventions
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Intervention Details:
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. 13C Phenylalanine Oxidation [ Time Frame: 8 hours ]
    Urine and breath will be collected during the study to measure the rate of 13C phenylalanine oxidation


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573439


Contacts
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Contact: Tonja C Nolen, MS 5013643309 acncstudies@archildrens.org
Contact: Audrey Martinez, MS, RD, LD 5013643309 acncstudies@archildrens.org

Locations
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United States, Arkansas
Arkansas Children's Nutrition Center Recruiting
Little Rock, Arkansas, United States, 72203
Contact: Tonja Nolen, MS    501-364-3309    acncstudies@archildrens.org   
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
More Information
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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04573439    
Other Study ID Numbers: 261235
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: February 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No