Protein Requirements for Active Children

(ChiPP Trial)

Overseen By Audrey Martinez, MS, RD, LD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Must not be taking: Protein metabolism drugs

Disqualifiers: Weight loss, Phenylketonuria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to stop taking nutritional supplements for at least 2 weeks before each study visit. If you are taking medications that affect protein metabolism, you may not be eligible to participate.

What data supports the effectiveness of the treatment Protein Requirements for Active Children?

Research indicates that children, especially those who are active, may need more protein to support growth and muscle development. Studies suggest that protein requirements for children might be higher than current recommendations, particularly for those engaging in physical activity, to ensure proper growth and lean body mass development. ^{1 2 3 4 5}

Is it safe for active children to have higher protein intake?

Current research suggests that while active children may need more protein than current guidelines recommend, most children already consume more than enough protein. However, the potential adverse effects of long-term high protein intake in children are not well-studied, so monitoring is advised. ^{1 2 4 5 6}

How does this treatment differ from other treatments for protein requirements in active children?

This treatment is unique because it focuses on determining the specific protein needs of active children, which are not currently addressed by standard protein recommendations. It uses advanced methods like stable isotope techniques to more accurately estimate protein requirements, considering the increased needs due to physical activity. ^{1 2 5 6 7}

Eligibility Criteria

This trial is for healthy boys and girls aged 8-10 who were part of a previous study (MI Energy). They should be normal weight, not taking supplements, free from infections, and classified as either sedentary or active based on fitness tests. All races and ethnicities are welcome.

Inclusion Criteria

My child does not currently have a viral infection like the flu or cold.

People of all ethnic backgrounds are eligible to participate.

People of all different ethnic backgrounds can participate.

Exclusion Criteria

I am on medication that affects how my body processes proteins.

I have lost more than 3 kg in the past 6 months.

Participants whose parents report any change in medical history that may potentially affect participation and/or study outcomes as determined by PI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or remote)

Assent/Consent and Run-in

Children and parents attend an assent/consent visit, followed by a 2-day run-in diet to ensure specific protein and energy intakes

2 days

1 visit (in-person or remote)

Testing

Participants undergo 7 testing days with different protein dosages, including breath and urine sample collection for phenylalanine oxidation measurement

7 days

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the testing phase

4 weeks

Treatment Details

Interventions

• Protein Requirements for Active Children

Trial Overview The study aims to determine if physically fit and active children have higher protein needs than currently recommended. Researchers will use the indicator amino acid oxidation technique to assess protein requirements in these children.

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Findings from Research

A meta-analysis of various studies has established new average protein requirements for children, ranging from 1.12 g/kg/day at 6 months to 0.74 g/kg/day at 10 years, based on maintenance needs and growth efficiency.

The safe level of protein intake, which ensures the needs of nearly all children in these age groups, is set at 1.43 g/kg/day for infants at 6 months and 0.91 g/kg/day for children at 10 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein requirements of infants and children. Garlick, PJ.[2013]

Recent research suggests that the protein requirements for children may be up to 60% higher than current estimates based on the nitrogen balance technique, which may underestimate their needs.

Children who are more physically active have increased protein requirements to support muscle growth and adaptations, highlighting the need for updated guidelines that consider activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Protein Requirements in Children: Methods for Consideration. Hudson, JL., Baum, JI., Diaz, EC., et al.[2021]

Children with mild to moderate renal insufficiency may benefit from a low protein diet (LPD) to potentially delay the progression of kidney issues, similar to findings in adults and laboratory animals.

A carefully planned LPD can safely reduce protein intake to the recommended daily allowance for children, provided there is extensive counseling, dietary supplements, and ongoing nutritional monitoring to ensure their growth and health needs are met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An approach to protein restriction in children with renal insufficiency. Raymond, NG., Dwyer, JT., Nevins, P., et al.[2019]

Children have higher protein needs than adults to support their growth, and these requirements are expressed as average dietary reference intakes that meet the needs of 97.5% of the population.

Critically ill children require even more protein due to increased protein turnover, and studies suggest that higher protein intake via enteral feeding can improve survival rates and clinical outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein Requirements of the Critically Ill Pediatric Patient. Coss-Bu, JA., Hamilton-Reeves, J., Patel, JJ., et al.[2017]

Current protein intake recommendations for young children are based on limited data and are estimates, with adequate intakes ranging from 0.6 to 2.9 g/kg, highlighting the need for more precise research.

Further studies using stable isotope methodology alongside traditional nitrogen balance protocols are necessary to better understand protein utilization and needs in growing children, as well as the impact of different protein sources on their diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal quantity and composition of protein for growing children. Rodriguez, NR.[2019]

Current Dietary Reference Intakes (DRI) for protein in children and youth are outdated and need revision, as they do not consider the effects of physical activity and lack an upper limit for protein intake.

New research is necessary to determine accurate protein requirements for children and youth, especially for those who are physically active, to ensure their dietary needs are met without risking adverse effects from high protein consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein Needs of Physically Active Children. Volterman, KA., Atkinson, SA.[2018]

In children recovering from protein-energy malnutrition, physical activity significantly enhances growth and lean body mass, highlighting the importance of both nutrition and activity for optimal development.

The study found that the essential amino acid requirements for 2-year-old children are lower than the current recommendations by FAO-WHO, suggesting a need to reassess dietary guidelines for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INCAP studies of energy, amino acids, and protein. Viteri, FE.[2017]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Protein requirements of infants and children. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Protein Requirements in Children: Methods for Consideration. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

An approach to protein restriction in children with renal insufficiency. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Protein Requirements of the Critically Ill Pediatric Patient. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Optimal quantity and composition of protein for growing children. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Protein Needs of Physically Active Children. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

INCAP studies of energy, amino acids, and protein. [2017]