Evaluation of the safety of a plant-based infant formula containing almonds and buckwheat in a neonatal piglet model

Authors: ROSA, FERNANDA - University Arkansas For Medical Sciences (UAMS); YELVINGTON, BROOKE - Arkansas Children'S Nutrition Research Center (ACNC); TERRY, NATHAN - Arkansas Children'S Nutrition Research Center (ACNC); TRIPP, PATRICIA - Arkansas Children'S Nutrition Research Center (ACNC); PITTMAN III, HOY - Arkansas Children'S Nutrition Research Center (ACNC); FAY, BOBBY - Arkansas Children'S Hospital; ROSS, TAYLOR - Arkansas Children'S Hospital; SIKES, JAMES - Arkansas Children'S Hospital; FLOWERS, JESSICA - Envigo; YOSEPH, FABIANA - Else Nutrition; Yeruva, Laxmi

Submitted to: Nutrients
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 3/31/2022
Publication Date: 4/2/2022
Citation: Rosa, F., Yelvington, B., Terry, N., Tripp, P., Pittman III, H.E., Fay, B.L., Ross, T.J., Sikes, J.D., Flowers, J.B., Yoseph, F.B., Yeruva, V. 2022. Evaluation of the safety of a plant-based infant formula containing almonds and buckwheat in a neonatal piglet model. Nutrients. https://doi.org/10.3390/nu14071499.
DOI: https://doi.org/10.3390/nu14071499

Interpretive Summary: Human milk is the gold standard for infant nutrition and health during the first year of life, while infant formula is recommended as an alternative nutrition source to human milk. In the US, approximately 25% of the infant formulas available in the market are soy-protein based. Studies demonstrated that soy-fed infants have a similar growth and development compared to breastfed infants. However, some concerns including the soy-based formula diet composition and the risk of lower bone mineralization among others risks have raised. Therefore, the aim of this study was to evaluate the safety and the effects on growth and blood biomarkers of a plant-based infant formula containing almonds, and buckwheat as the main ingredients. From postnatal day (PND) 2 to 21, piglets were fed a dairy-based milk formula or a plant-based formula and all piglets were euthanized at day 21. No diarrhea was observed after PND 8 and all the piglets completed the trial. Body growth, kcal intake, and intestinal organs development was similar between the two groups. Blood glucose was higher in the dairy-based fed piglets relative to the plant-based at 2 weeks of age. Liver function biomarkers levels were greater in the blood of the plant-based compared to the dairy-based fed group. In addition, calcium levels were higher in the plant-based fed piglets at 1 week of age. Hematological parameters were within the reference range in both groups. Thus, the plant-based formula tested in this study was well-tolerated by the piglets and supported similar growth to dairy-based milk formula. Additionally, the positive clinical outcomes observed in the blood of the plant-based fed group suggest an improvement in the liver function during the neonatal period in comparison to dairy-based formula feeding.

Technical Abstract: A randomized neonatal piglet trial was conducted to evaluate the safety and the effects of a plant-based formula containing almonds and buckwheat as the main ingredients on growth and blood parameters. From postnatal day (PND) 2 to 21, piglets were fed a dairy-based milk formula (Similac Advance) or a plant-based formula (Else Nutrition) and all piglets were euthanized at day 21. No diarrhea was observed after PND 8 and all the piglets completed the trial. Body growth, kcal intake, and intestinal organs development was similar between the two groups. Blood glucose was higher in the dairy-based fed piglets relative to the plant-based at 2 weeks of age. Liver function biomarkers levels were greater in the blood of the plant-based compared to the dairy-based fed group. In addition, calcium levels were higher in the plant-based fed piglets at 1 week of age. Hematological parameters were within the reference range in both groups. Thus, the plant-based formula tested in this study was well-tolerated by the piglets and supported similar growth compared to dairy-based milk formula. Additionally, the complete blood count parameters were within the normal range in all piglets. Therefore, the positive clinical outcomes observed in the blood of the plant-based fed group suggest an improvement in the liver function during the neonatal period in comparison to dairy-based formula fed group.