ByHeart Announces New Data Indicating that its First-of-its-Kind, U.S.-Made Infant Formula Improves Sleep Benefits in Infants, According to Clinical Trial Results

May 03, 2023 

ByHeart was selected to present its industry-leading findings from its clinical trial at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2023 medical conference

These findings, which show babies on ByHeart wake up less overnight to feed and sleep longer between feeds, build on ByHeart's previously announced clinically proven easy digestion and tolerance benefits published in the Journal of Pediatric Gastroenterology and Nutrition

ByHeart is the first U.S. infant formula with a patented protein blend that gets closest to breast milk with clinically proven easy digestion and sleep benefits and certified cleanest ingredients

NEW YORK, May 3, 2023 /PRNewswire/ -- Today, ByHeart, a next-generation baby nutrition company, announced new data from its clinical trial demonstrating that its infant formula improves sleep benefits in infants. The data collected in the clinical trial established that four-month-old infants who consumed ByHeart's infant formula, at this important time during sleep development, woke up less to feed overnight and slept longer between feeds, compared to infants who consumed another infant formula. These findings build on previously announced ease of digestion and tolerability data published in the Journal of Pediatric Gastroenterology and Nutrition. ByHeart's patented protein blend includes lactoferrin and alpha-lactalbumin, the two most abundant proteins in breast milk; the company is the first to include alpha-lactalbumin at breast milk levels in infant formula in the American market. Babies fed ByHeart had significantly fewer spit-ups and softer stools than babies fed another infant formula, and more closely resembled breastfed infants.

Alpha-lactalbumin has high tryptophan levels compared to other food-derived proteins. This study further confirms that consumption of alpha-lactalbumin increases blood levels of tryptophan and the tryptophan to large neutral amino acid ratio, a measure of available tryptophan. Tryptophan is influential in the sleep-wake cycle and may improve sleep quality in infants.

"At ByHeart, we don't believe in relying on old ingredient data to make product claims. We demonstrated the benefits of our next-generation infant formula in a major clinical trial that we conducted over many years because parents deserve both a better product and a better understanding of how it is supporting baby's systems in this critical time in development," said Ron Belldegrun, CEO of ByHeart. "For too long, parents have had to make compromises when choosing a single formula. They've asked themselves, 'Do I want the one that supports the immune system or easy digestion? What about sleep benefits or brain development? Do I want the one with clean ingredients?' We don't believe parents should have to choose between benefits. Breast milk provides all-in-one benefits, so infant formula should too. This is what we strived to deliver with ByHeart."

"ByHeart's commitment to advancing infant nutrition and providing the best possible infant formula for babies is evidenced by their completion of the largest clinical trial by a new brand in over 25 years. I am thrilled to see how they are continually taking breast milk science from the academic level and translating it into better formulas. No other company in the infant formula industry is accomplishing what ByHeart is achieving," said Steven Zeisel, MD, Ph.D., member of ByHeart's Scientific Advisory Board.

The study was a randomized, double-blind, multicenter trial that included healthy, term infants with a birth weight greater than 2500g, age less than 14 days, and fifth to ninety-fifth percentile of WHO Growth Standards. Formula-fed infants were randomized to receive either ByHeart's patented protein blend formula or a standard formula with skim milk and whey protein concentrate. Formula intake records were completed every four weeks for 24 weeks, and blood was drawn at 16 weeks of life in a subgroup of infants without any complementary food intake.

For more detailed information, additional data, and insights from ByHeart's clinical trial study, visit https://byheart.com.