Independent Study Demonstrates Safety of Including Multiple Potential Food Allergens in Infant Diets Using New … – Business Wire (press release)
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
“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.