Pea power: could Plant-Based formulas help toddlers thrive?
NCT ID NCT07231705
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing two plant-based formulas made from pea protein in 40 children aged 1 to 2 years who get most of their nutrition from formula. The goal is to see if these formulas support healthy growth and are well-tolerated over 24 weeks. Researchers will also check body composition, vitamin levels, and gut health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pea protein-based formulas (Kate Farms Standard 1.2 and Peptide 1.0)
- What this could lead to
- If successful, this could show that plant-based formulas are a safe and effective option for supporting healthy growth in toddlers who rely on formula.
- What could go wrong
- This is a small, early-stage study with only 40 children, so results may not apply to all. It does not compare the formulas to standard options, and some children may not tolerate the formula well.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 17 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Children, male or female, aged 12 through 17 months (for premature infants, we will use corrected age) * Children with a weight-for-length z score between ≥ -1.5 at enrolment * Children obtaining via formula feeding ≥ 80% of their total energy intake at enrolment and expected to continue to require such formula intake for the next 24 weeks * Children from families who are willing and able to comply with the requirements of the protocol * Written informed consent from the parent or legal guardian * Parent/caregiver or legal guardian must be able to read, write, and understand English Exclusion Criteria: * Children with known or suspected complex gastrointestinal anomalies or dysfunction, hepatic or renal dysfunction, or inherited metabolic disorders, suspected or diagnosed conditions associated with malabsorption (e.g. cystic fibrosis) (Note: For hepatic dysfunction, a conjugated bilirubin \>2.0 mg/dL and for renal dysfunction child should not meet any of the Pediatric Risk, Injury, Failure, Loss, End Stage Renal Disease (pRIFLE) criteria for renal disease (estimated creatinine clearance decreased by 25% by the Schwartz formula or urine output \<0.5 mL/kg per hour over the previous 8 or more hours) or has chronic medical renal disease. We will not obtain labs to exclude children. If children are noted to have liver disease or renal disease in their chart, we will look at their labs to ensure that they do not meet exclusion criteria). * Children with tracheostomy and/or inspired oxygen via nasal cannula or children receiving diuretics. * Children with known or suspected genetic and/or metabolic inborn errors of metabolism conditions known to interfere with growth or body dysmorphology that can interfere with obtaining standard anthropometric measurements (weight, length, head circumference, and arm circumference) * At study entry, children expected to consume on average more than 20% of their energy intake from non-formula sources of nutrition: solids, expressed breast milk and /or parenteral nutrition. * Child requiring or expected to have an energy requirement \< 80 kcal/kg per day - Breastfeeding child (who is feeding at the breast \> 2 times per day) * Child likely to undergo major surgery during the duration of the study * Child with a nasogastric tube that is unlikely to get a gastrostomy tube during the duration of the study * Principal Investigator's uncertainty about the willingness or ability of the parent/caregiver to comply with the protocol requirements * Children whose parent is younger than the legal age of consent * Children with known allergy to pea protein or soy or peanuts. * Children with a parent or a sibling with a known allergy to pea protein or soy or peanuts.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States