“Breast milk is the gold standard of infant nutrition, and we are better equipped than ever to leverage the exciting advances in breast milk research to create infant formulas that approximate breast milk and provide babies with both functional nutrition and the highest quality, cleanest ingredients,” said ByHeart co-founder and CEO Ron Belldegrun. “Infant formula manufacturers have a responsibility to ensure that product innovation and research keep pace with science – to benefit the future health of babies.”
ByHeart, which was launched in the commercial market in March 2022, began development of its first infant formula in 2016 and identified the biggest gap between breast milk and other infant formulas on the shelf: the protein blend. ByHeart’s formula recipe has been informed by breast milk research and pediatric nutrition science that demonstrates the role of protein in all-in-one benefits including easy digestion, immune support, healthy brain and intestine, less sputum and softer stools. ByHeart recognized the need to rewrite the formula formula recipe to develop a first-of-its-kind, high-quality protein blend that includes the two key proteins in breast milk – alpha-lactalbumin and lactoferrin – and features a whey to casein ratio of 80 :20 (incorporating partially hydrolyzed whey), plus being the first in the US to include grass-fed organic whole milk (vs. the skim milk used by other on-shelf formulas). ByHeart’s protein blend comes closest to breast milk of any formula on the market and provides easy digestion benefits for baby without the use of “filler” ingredients like corn syrup, maltodextrin , palm oil or soy like so many other “mild” formulas on the shelf.
The company’s double-blind randomized controlled clinical trial, the only one conducted by a new entrant to the infant formula market in recent years and the largest conducted by a new brand of infant formula in more than 25 years, has assessed the impact of this protein blend and assessed growth, safety, and tolerability, including healthy, single, and full-term infants, enrollment age ≤ 14 days. The national multi-site clinical trial, which lasted 6 months with more than 300 babies, compared ByHeart’s formula to both commercial infant formula and a human breast milk reference arm.
“I am extremely proud of the thoroughness of the design and execution of this study, as we went far beyond industry standards,” explained Dr. Bruce Germanauthor of the study and eminent professor of food science and technology at the University University of California, Davis. “The fact that the study was done – not to mention a new brand – is also remarkable, as almost all changes to infant formula these days are made by adding ingredients, thus avoiding a trial. complete like this.”
Clinical data from ByHeart has demonstrated improved parent-reported gastrointestinal tolerance and more efficient growth with less daily prep and protein intake, supporting that their new formula can reduce the metabolic load of overfeeding by protein associated with infant formula. ByHeart’s trial showed that the composition of the formula resulted in more efficient growth, demonstrating the high quality of the ingredients:
- The average daily rate of weight gain (g/d) between trial enrollment and 24 weeks was 26.7 (SD = 5.2) in the ByHeart group (SF) and 26.1 (SD = 4.7) in the Commercial Formula (CF) group.
- Formula intake by weight (oz/kg/d) was estimated to be lower in the SF group (-0.33 oz/kg/d, 95% CI: -0.66, -0.01, p =0.05) than in the CF group, for a decrease in protein intake in the SF group of -0.13 g/kg/d (95% CI: -0.26, 0.00, p= 0.05) compared to CF group
- Energy efficiency per oz/mL of formula was 14.0% (95% CI: 8.3%, 19.7%), 13.0% (95% CI: 6.0%, 20, 0%) and 18.1% (95% CI: 9.4%, 26.8%) weight, length and HC, respectively, in the SF group compared to the CF group.
- The combination of essential and conditionally essential amino acids was superior in the SF group compared to the CF group (p=0.048)
The ByHeart formula also demonstrated better tolerance (easy digestion) with fewer regurgitations and softer stools, with a significantly lower mean number of regurgitations over time in the SF group compared to the CF group (p=0, 01), and a mean softer stool consistency in the SF group compared to the CF group (mean score difference 0.39, 95 CI 0.27, 0.52, p
dr. Devon KuehnByHeart’s chief medical officer and neonatologist whose team oversaw the analysis of the trial and the development of the published manuscript, explained, “ByHeart was bold in rewriting the formula formula, and even more progressive as a the only new entrant in years to run our own clinical trial to provide the reassurance parents deserve when choosing a product to feed their babies.Infant formula needs real innovation, and it is essential that the category is held to a new level of research – for every formula on the market – so that we can effectively evolve infant nutrition. We are proud to have been rewarded with the publication of this data by Journal of Pediatric Gastroenterology and Nutritionas it represents a significant leap forward in the nutrition provided by easily digestible infant formula. »
Founded in 2016, based in New York City with manufacturing facilities at Pennsylvania, ByHeart is a next-generation baby nutrition company dedicated to giving parents choices for a better future in nutrition. ByHeart is the first new infant formula manufacturer to be registered with the FDA in over 15 years, and ByHeart’s next generation of easy-to-digest infant formula is produced in their own facility, driven by nutritional excellence and a quality farm-to-formulaVerified™ program. For more information about ByHeart, visit https://byheart.com/.
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