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Official title Protein Requirements for Active Children
ClinicalTrials.gov ID: NCT04573439
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 10. Healthy volunteers may be eligible.
You may be able to join 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)
You likely can't join 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 10 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.