title: A 3-week dietary safety study of octenyl succinic anhydride (OSA)-modified starch in neonatal farm piglets.
abstract: Octenyl succinic anhydride (OSA)-modified starch functions as both an emulsifier and emulsion stabilizer in foods, and is intended for use in infant formula, follow-on formula, and formulae for special medical purposes. These formulae predominantly include extensively hydrolyzed protein or free amino acids, rather than intact protein, which otherwise would provide emulsifying functionality. The study objectives were to evaluate (1) the safety of OSA-modified starch after three weeks of administration to neonatal farm piglets, beginning 2 days after birth and (2) the impact of OSA-modified starch on piglet growth. OSA-modified starch was added to formula at concentrations of 2, 4, and 20 g/L. The vehicle control, low-dose, and mid-dose diets were supplemented with Amioca™ Powder to balance the nutritional profiles of all formulations. There were no test article-related effects of any diet containing OSA-modified starch on piglet growth and development (clinical observations, body weight, feed consumption), or clinical pathology parameters (hematology, clinical chemistry, coagulation, urinalysis). In addition, there were no adverse effects at terminal necropsy (macro- and microscopic pathology evaluations). Therefore, dietary exposure to OSA-modified starch at concentrations up to 20 g/L was well tolerated by neonatal farm piglets and did not result in adverse health effects or impact piglet growth.
authors.affiliation: Regulatory Affairs, Abbott Nutrition, Abbott Laboratories, 3300 Stelzer Road, Columbus, OH 43219, USA. Electronic address: brinda.mahadevan@abbott.com.
authors.forename: Brinda
authors.initials: B
authors.lastname: Mahadevan
authors.affiliation: MPI Research, Inc., 54943 North Main Street, Mattawan, MI 49071, USA. Electronic address: Bjorn.Thorsrud@mpiresearch.com.
authors.forename: Bjorn A
authors.initials: BA
authors.lastname: Thorsrud
authors.affiliation: ToxStrategies, Inc., 3260 Blume Drive, Suite 420, Richmond, CA 94806, USA. Electronic address: gbrorby@toxstrategies.com.
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Brorby
authors.affiliation: Regulatory Affairs, Abbott Nutrition, Abbott Laboratories, 3300 Stelzer Road, Columbus, OH 43219, USA. Electronic address: heather.ferguson@abbott.com.
authors.forename: Heather E
authors.initials: HE
authors.lastname: Ferguson
mesh_terms: D000818:Animals; D000831:Animals, Newborn / Q000254:growth & development; D003257:Consumer Product Safety; D004032:Diet; D004305:Dose-Response Relationship, Drug; D005243:Feces / Q000737:chemistry; D005260:Female; D059022:Food Safety; D008297:Male; D013213:Starch / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity; D013552:Swine
chemical_list: C551966:octenyl succinic anhydride-modified starch; D013213:Starch
keywords: Infant nutrition; Modified starch; Octenyl succinic anhydride; Piglet