PW21 - CLINICAL BENEFITS OF UNIQUE PEA PROTEIN FORMULAS FOR PEDIATRICS DEMONSTRATED USING REAL-WORLD EVIDENCE

PW21

CLINICAL BENEFITS OF UNIQUE PEA PROTEIN FORMULAS FOR PEDIATRICS DEMONSTRATED USING REAL-WORLD EVIDENCE

V. Millovich^1,*, G. Lopes², M. Tyagi², Z. Cao², I. Olsen¹, C. J. Valentine¹

¹Kate Farms, Goleta, ²Premier Inc, Charlotte, United States

Rationale: Plant-based nutrition positively impacts clinical outcomes. Unique, organic yellow pea protein plant-based formulas (PPPBF) with prebiotic fiber are accumulating evidence of good tolerance in pediatrics. Our study describes differences in clinical outcomes in pediatric outpatients using these formulas or dairy/soy protein (DSP) formulas.

Methods: This retrospective study utilized real-world data on pediatric outpatients (1-17 years) from a closed claims database encompassing 1,400 hospitals across all US regions. Any prescription claim for a nutritional formula (June 1, 2020, to September 30, 2023) was included, and the date of the first prescription claim was used as the index date. Patients were assigned to the PPPBF or DSP group. Risk of mortality was measured using the Charlson Comorbidity Index (CCI) score. Study outcomes included malnutrition, weight loss, use of GI medications, and a summary score of any gastrointestinal intolerance (AGII) symptom; GI symptoms included flatulence, abdominal pain, constipation, diarrhea, and nausea/vomiting. After IRB approval, unadjusted descriptive analysis was used to compare the outcomes 180 days before (pre-index) and 90 days after (post-index) formula initiation and between the PPPBF and DSP groups.

Results: The PPPBF group included 588 pediatric patients, and the DSP group had 5,834, from 60 US hospitals, with an average age of 7.8yr (SD=4.3) and 8.7yr (SD=4), respectively. Patients in the PPPBF group were sicker at baseline, with a mean CCI score of 0.5 (SD = 0.9) vs. 0.4 (SD=1.0) in the DSP group (p-value = <0.001). Prevalence rates of AGII were 17.5% in the 180-day pre-index period and 10.4% in the 90-day post-index period in the PPPBF group vs. 11.1% and 7.2% in DSP. More improvement was seen in the PPPBF group vs. the DSP group between the pre- and post-index periods based on a decrease in the prevalence rate of AGII despite no significant differences in GI medication use post-index (all p-values >0.05). Other PPPBF group pre- and post-index period prevalence rates were: malnutrition (3.2%; 1.4% = 1.6% absolute decrease), weight loss (4.6%; 1.9% = 2.4% absolute decrease), constipation (11.6%; 5.1% = 6.1% absolute decrease), and nausea/vomiting (7.7%; 4.1% = 3.4% absolute decrease). Other DSP group pre- and post-index period prevalence rates were: malnutrition (1.4%; 0.9% = 0.5% absolute decrease), weight loss (2.2%; 1.2% = 1.0% absolute decrease), constipation (6.4%; 4.0% = 2.4% absolute decrease), and nausea/vomiting (4.8%; 2.6% = 2.2% absolute decrease).

Conclusion: This study describes the largest known US cohort of pediatrics using complete, unique yellow pea protein plant-based formulas (PPPBF) as outpatients. Compared to the DSP group, the use of PPPBF was associated with a decrease in GI intolerance, without an increase in GI medication use, in a sicker pediatric population. Future research is needed to calculate a pediatric-specific acuity score in this cohort and test if the improvements in GI intolerance with the use of these yellow pea protein plant-based formulas result in decreased health care utilization in the US and globally.

Disclosure of Interest: V. Millovich Shareholder at: 22000, Other: Employee, G. Lopes: None declared, M. Tyagi: None declared, Z. Cao: None declared, I. Olsen Other: Employee, C. Valentine Other: Employee