ByHeart, a company that specializes in baby nutrition, has reported that clinical trial data for their "next-generation" infant formula demonstrates that it can improve the sleep patterns of four-month-old babies. According to a recent news release, the company claims that infants who were fed ByHeart's formula woke up less frequently during the night to feed and experienced longer intervals between feedings in comparison to babies who were fed another infant formula.
The company's CEO, Ron Belldegrun, ByHeart has demonstrated the benefits of their infant formula through a major clinical trial, rather than utilizing old ingredient data to make product claims. Their clinical trial has been conducted over many years and was a randomized, double-blind, multicenter trial. Infant participants were healthy, term infants with a birth weight greater than 2500g, aged less than 14 days and fifth to ninety-fifth percentile of WHO Growth Standards according to PR Newswire.
"At ByHeart, we don't believe in relying on old ingredient data to make product claims," Belldegrun said. "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."
Infants fed with the formula were randomly assigned to receive either ByHeart's patented protein blend formula or a standard formula containing skim milk and whey protein concentrate. For a duration of 24 weeks, formula intake records were maintained every four weeks, and a subgroup of infants who did not consume any complementary food had their blood drawn at 16 weeks of age.
"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."
As per the company's press release, this study has validated that the intake of alpha-lactalbumin results in heightened tryptophan levels in the bloodstream and a rise in the tryptophan to large neutral amino acid ratio. Tryptophan plays a critical role in regulating the sleep patterns of infants and is found in alpha-lactalbumin in greater quantities than in other protein sources.
A member of ByHeart's Scientific Advisory Board, Dr. Steven Zeisel, Ph.D. cosigned ByHeart's work by highlighting their cutting-edge innovation.
"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," Dr. Zeisel said.
ByHeart has distinguished itself as the first American company to incorporate alpha-lactalbumin into its infant formula at levels similar to those found in breast milk by including lactoferrin and alpha-lactalbumin, which are the two most abundant proteins found in breast milk. This exclusive strategy leads to a decrease in spit-ups, softer stools and a closer resemblance to breastfed infants. These results complement prior reports on the formula's ease of digestion and user-friendliness.
"I am thrilled to see how they are continually taking breast milk science from the academic level and translating it into better formulas," Dr. Zeisel said. "No other company in the infant formula industry is accomplishing what ByHeart is achieving."
