HealthyChiPPNCT04573439
Protein Requirements for Active Children
A study testing Dietary Supplement: Dietary supplement: Protein intake in people with Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary Supplement: Dietary supplement: Protein intake
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72203
Tonja Nolen, MS, 501-364-3309, acncstudies@archildrens.org
About this study
Official title: Children's Protein Requirements With Physical Activity: The ChiPP Study
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.
Read the 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
- Being tested
- Dietary Supplement: Dietary supplement: Protein intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Dietary supplement: Protein intakeDietary 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
13C Phenylalanine Oxidation
Urine and breath will be collected during the study to measure the rate of 13C phenylalanine oxidation
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Aug 2021
- Primary completion30 Jun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva C Diaz Fuentes, MD, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573439
- Sponsor's protocol ID
- 261235
- Acronym
- ChiPP
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2020
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Protein Requirements With Physical Activity: The ChiPP Study
- ClinicalTrials.gov ID
- NCT04573439
- Acronym / sponsor ID
- ChiPP / 261235
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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.
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- • Participants who have been excluded from participation in the study MI Energy (IRB Protocol: 260376)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: Dietary supplement: Protein intakeOral 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. | Dietary supplement | – |
Primary outcome
13C Phenylalanine Oxidation
Time frame: 8 hours
Urine and breath will be collected during the study to measure the rate of 13C phenylalanine oxidation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva C Diaz Fuentes, MD principal investigator
Arkansas Children's Nutrition Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Dietary supplement: Protein intake in people with Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tonja C Nolen, MS (5013643309, acncstudies@archildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13C Phenylalanine Oxidation (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.