Pea power: could Plant-Based formulas help toddlers thrive?

NCT ID NCT07231705

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

12 to 17 months

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States