MENLO PARK, Calif.--(BUSINESS WIRE)--Initial data from an independent study strongly suggesting that SpoonfulOne™ Daily Food Mix-In is safe and well tolerated by infants was presented as an abstract during the poster session today at the European Academy of Allergy and Clinical Immunology’s Pediatric Allergy and Asthma Meeting (PAAM) in London. SpoonfulOne, made by science-based consumer products company Before Brands™, Inc., is a daily dietary supplement powder blend of gentle, measured portions of the proteins in foods that end up causing 90 percent of food allergies, plus 400 IU of Vitamin D. The study was conducted by leading food allergy researchers at Northwestern University Feinberg School of Medicine with funding support provided by Before Brands.
Primary investigator, Jane Holl, MD, MPH, led the randomized, blinded, placebo-controlled nationwide study in 705 healthy infants. The study, “Introduction and Maintenance of Early Adaptive Training protein blends in support of Infant Nutritional Goals: safety and acceptability" (the I’M EATING study), recruited full-term infants, 5-11 months of age, without reported severe eczema or diagnosed food allergy. Parents were instructed to add one packet of placebo or unbranded SpoonfulOne powder to their infant’s feeding once daily. Parents were also instructed to observe their infant for two hours after the feeding to assess any sign or symptoms of an allergic reaction and to record any allergy-related and non-allergy symptoms.
In more than 8,800 feedings of SpoonfulOne, no infant was reported to have had any sign or symptoms of an allergic reaction. Future studies are underway to assess the effect of this supplement on immunologic responses to the allergenic proteins and the longer-term incidence of food allergy.
“The safety and tolerability of SpoonfulOne shown in this study provide highly reliable data for parents and pediatricians seeking scientifically robust findings in support of the benefits of feeding infants multiple, potentially allergenic foods contained in SpoonfulOne early and consistently. Given the 88 percent study completion rate, it is clear that SpoonfulOne was easy for parents to incorporate into their infant’s regular feeding routine, which is encouraging given the adherence challenges that often arise when parents attempt to consistently feed their infant a range of foods,” said Holl.
SpoonfulOne consists of a patented formula that was developed based on science demonstrating that an “early and often” approach to incorporating potentially allergenic foods into children’s diets may reduce the risk of developing a food allergy. However, past research shows that it’s difficult for parents to consistently incorporate multiple potential allergens into their children’s diets. Notably and widely-cited, the Enquiring About Tolerance (EAT) study published in the New England Journal of Medicine in 2016 showed that introducing a diverse set of potential allergens (wheat, dairy, egg, peanut, fish and sesame) in infant diets was safe and reduced the risk of developing a food allergy by two-thirds, for those who adhered to the regimen. SpoonfulOne can be mixed once a day into a wide range of foods, making it easy to adhere to the recommendation of feeding a diverse range of potential allergens to infants “early and often”.
“The data from the I’M EATING study provide further evidence that the specific SpoonfulOne formula containing sixteen of the most commonly allergenic foods is well-tolerated by infants,” said Dr. Wendy Sue Swanson, pediatrician, Chief Medical Officer, Before Brands, Inc. and Chief of Digital Innovation, Seattle Children’s Hospital. “These data provide parents and pediatricians with even more peace of mind that a wide range of potential allergens can be safely included in infants’ early solid diet with SpoonfulOne. We are excited that along with Vitamin D, these foods can be fed easily and support the critical development of a healthy, balanced immune system right from the start.”
SpoonfulOne is available via monthly subscription at www.SpoonfulOne.com.
About Before Brands™, Inc.
Before Brands is a science-based health and wellness company dedicated to bringing innovative nutritional products directly to families. Our product development builds on a growing body of evidence in support of nutritional strategies that include potentially allergenic foods as a regular part of a healthy diet. The Company’s first line of products: SpoonfulOne™, includes a patented blend of real food proteins and vitamin D designed to help provide children with gentle and consistent immune system support, before foods become allergens. SpoonfulOne™ is based on intellectual property developed by Dr. Kari Nadeau, Director of the Sean N. Parker Center for Allergy and Asthma Research and Stanford University, and licensed to Before Brands™ on a global, exclusive basis. Before Brands is a member of the Council for Responsible Nutrition.