Plant-Based Formula for Toddler Nutrition
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how two pea protein-based formulas from Kate Farms, the Kate Farms Standard 1.2 and Peptide 1.0, affect growth and health in toddlers aged 12 to 17 months who primarily rely on formula for nutrition. Researchers seek to determine if these formulas support healthy growth, good nutrient absorption, and a balanced gut microbiome in tube-fed children. A suitable candidate for this trial is a toddler who receives most of their daily nutrition from formula. As an unphased trial, this study provides a unique opportunity to enhance understanding of the nutritional benefits of innovative formulas for toddlers.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both Kate Farms Pediatric Standard 1.2 and Pediatric Peptide 1.0 formulas are safe for children aged 1 to 13. The Pediatric Standard 1.2 formula provides 12 grams of pea protein and 300 calories per shake, supporting healthy growth. Tests have confirmed it is free from harmful heavy metals like lead and mercury.
The Pediatric Peptide 1.0 formula features pea protein broken down for easier digestion, designed to be gentle on the stomach. It includes 27 essential vitamins and minerals and excludes common allergens, making it suitable for children with digestive issues or allergies.
Both formulas are plant-based and organic, meeting strict nutritional standards. Their safety and use in various pediatric settings suggest they are generally well-tolerated by children.12345Why are researchers excited about this trial?
Researchers are excited about these plant-based formulas for toddler nutrition because they offer a unique alternative to traditional milk-based options. Unlike standard formulas that often rely on cow's milk or soy, these treatments use pea protein, making them suitable for children with dairy or soy allergies. Additionally, the Kate Farms formulas are designed to be easily digestible, which could benefit toddlers with sensitive stomachs or digestive issues. This innovative approach not only broadens the nutritional options available but also addresses specific dietary needs more effectively.
What evidence suggests that these formulas might be effective for toddler nutrition?
This trial will evaluate two pea protein-based formulas: Kate Farms Pediatric Standard formula 1.2 (KF-PS) and Kate Farms Standard Pediatric Peptide Formula 1.0 (KF-PP). Studies have shown that the Pediatric Standard 1.2 formula, containing 12 grams of organic pea protein and 300 calories per shake, helps children aged 1 to 13 years gain weight and grow healthily. This plant-based formula is easy to digest and suitable for kids with dietary restrictions. Research suggests that plant-based formulas like this one can improve gut health and overall nutrition when used as part of enteral nutrition, which involves feeding through a tube or by mouth to meet nutritional needs.
For the Pediatric Peptide 1.0 formula, a survey found that 90% of parents noticed improved tolerance in their kids after switching. It uses hydrolyzed (broken down) pea protein, making it easier to digest, especially for kids with stomach issues. Both formulas are designed to provide complete nutrition and meet the specific needs of children who are tube-fed.14567Who Is on the Research Team?
Praveen Goday, MD
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pea protein-based formulas for nutritional needs
Follow-up
Participants are monitored for growth, tolerance, and nutritional status after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Kate Farms Standard 1.2 or Peptide 1.0
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The study intervention will be 2 pea protein-based formulas Kate Farms Pediatric Standard formula 1.2 (KF-PS) and Kate Farms Standard Pediatric Peptide Formula 1.0 (KF-PP).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kate Farms Inc
Lead Sponsor
Nationwide Children's Hospital
Collaborator
Citations
Pediatric Peptide 1.0
In a small, single-site survey, 90% of parents reported improved tolerance in their kids after switching to Kate Farms. Designed for Tube Feeding. Pediatric ...
Kate Farms Pediatric Formulas
Complete plant-based, organic peptide formula with hydrolyzed pea protein. Made for tolerance to provide nutritional support for pediatric patients with ...
Patient-reported outcomes on gastrointestinal tolerance and ...
Enteral Nutrition through a feeding tube or orally can improve patient outcomes when tolerated to achieve nutritional requirements.
Pediatric Nutrition
Pediatric Peptide 1.0 · Calories: 250kcal. Total Fat: 11g. Total Carbohydrate: 30g. Protein: 9g ; Pediatric Standard 1.2 · Calories: 300kcal. Total Fat ¹ ²: 12g.
5.
katefarms.com
katefarms.com/resources/discover/articles/5-reasons-to-try-kate-farms-pediatric-peptide-1-0-strawberry/5 Reasons to Try Kate Farms Pediatric Peptide 1.0 ...
Plant-based peptide formulas help provide nutritional support for children who experience impaired GI function or malabsorption, especially those with dairy ...
6.
7157e75ac0509b6a8f5c-5b19c577d01b9ccfe75d2f9e4b17ab55.ssl.cf1.rackcdn.com
7157e75ac0509b6a8f5c-5b19c577d01b9ccfe75d2f9e4b17ab55.ssl.cf1.rackcdn.com/RECMKNSA-PDF-1-469742-4447450818.pdfKate Farms® Peptide Formulas
Plant-based, organic, sole-source or supplemental nutrition made with hydrolyzed pea protein for oral or tube feeding use in children 1-13 years of age. Made ...
Choose Kate Farms Pediatric Peptides
Starting with a well-tolerated formula first may help support adherence and reduce malnutrition risks. Feeding intolerance is the #1 reason and can impact ...
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