Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
Kate Farms Inc
Summary
The purpose of this prospective study is to evaluate the growth and enteral tolerance of two pea protein-based formulas from Kate Farms in children aged 12 to 17 months who are expected to meet most of their nutritional needs through formula. It is hypothesized that the Pediatric Standard 1.2 and Pediatric Peptide 1.0 formulas will support healthy growth in children between 1 and 2 years of age. The study will assess the impact of these formulas on growth, tolerance, body composition, micronutrient levels, and gut microbiome health in tube-fed children. Formula will be provided for 24 weeks.
Description
This is a prospective cohort study. Forty children ages 12-17 months who rely on formula for at least 80% of their nutritional needs (by mouth of tube feeding) are expected to continue this dependence for the next 6 months will be recruited. Children will be recruited from the Feeding Program, GI clinic and Complex Care clinic at Nationwide Children's Hospital in Columbus, Ohio. The study will be introduced to the patient by the provider during a routine clinic visit. Parent consent will be obtained from one of the research investigators during the clinic visit. The objectives are to study th…
Eligibility
- Age range
- 1–1 years
- Sex
- All
- Healthy volunteers
- No
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 unders…
Interventions
- Dietary SupplementKate Farms Standard 1.2 or Peptide 1.0
Kate Farms Standard 1.2 or Peptide 1.0 formulas will be provided by mouth or via tubefeeding. Study children will be fed the formula for a period of up through 24 weeks.
Location
- Nationwide Children's HospitalColumbus, Ohio