Formula Ingredients for Infant Health

Why would any self-respecting parent allow his or her baby to hit the bottle before age one? Especially when there is a perfectly good-perhaps better-alternative, and it costs nothing?

Virtually all authorities acknowledge that breastfeeding is best for infants. Even the companies that make and sell formula-to the tune of more than $3 billion a year in the United States alone-don’t dispute this.

Nonetheless, believing, or knowing, that breastfeeding gives a kid the best shot at a healthy childhood is not enough. Wishing won’t make it so. With two-earner households now the norm, millions of moms will continue to opt for the convenience of formula.

This opens enormous opportunity for suppliers of nutritional ingredients, while at the same time placing great responsibility on their shoulders.

Managing the Microflora

“Breastfeeding is considered a gold standard,” says Joseph O’Neill, president and general manager of Beneo Inc. (Morris Plains, NJ). “Breastfed babies have a different microflora, mainly composed of bifidobacteria and lactobacilli, compared to bottle-fed infants that display a more complex flora dominated by clostridia, bacteroides, and streptococci.” The higher amount of bifidobacteria is said to help protect infants from infection.

“It has also been observed that breastfed infants grow and develop differently with reduced incidence of allergy and childhood obesity,” O’Neill says. “Whereas human milk contains about 8% of total carbohydrates in the form of prebiotic oligosaccharides, infant milk formulas do not contain such prebiotics unless they are enriched.”

This is why Beneo has introduced Orafti Synergy1, an oligofructose-enriched inulin derived from chicory, which O’Neill says helps stimulate the growth of bifidobacteria and lactobacilli in the gut.

O’Neill cites a 2013 study conducted in Spain in which a research team led by Ricardo Closa Monasterolo, PhD, demonstrated that neonates receiving a formula supplemented with Beneo’s prebiotic fiber showed a microflora composition similar to that of breastfed infants. “They had a higher proportion of bifidobacteria, softer stools, and higher deposition frequency compared to the control group receiving maltodextrin,” says O’Neill.

Another oligosaccharide solution comes from FrieslandCampina Domo, a Dutch firm with U.S. sales offices in Paramus, New Jersey and Chicago. Erik Torringa, growth initiatives manager for ingredients, says the company specializes in base formulas and total formula for the infant nutrition industry.

“We are fascinated by all the nutrients contained in milk,” says Torringa. Evidence of this can be seen in the company’s introduction of galacto-oligosaccharides (GOS) for the infant feeding market, under the name Vivinal GOS.

According to Torringa, the ingredient is available in a syrup version, two powder varieties, and as a glycosylated protein from milk, called Vivinal Lactoferrin. Benefits include promotion of the growth of bifidogenic bacteria, contribution to a healthy balance of intestinal flora, and support of the immune function.

Jeske Hageman, a researcher for FrieslandCampina, notes that GOS are non-digestible and do not easily break down when exposed to digestive enzymes. Therefore, they reach the intestine almost completely intact, where they can do the most good, he says.

“Because breast milk is best for babies, human milk is a natural source of inspiration for infant nutrition,” says Hageman, who works out of Wageningen, The Netherlands. He says there are about 200 different human milk oligosaccharides (HMOs) found in breast milk. This compares with cow’s milk, where oligosaccharides are “hardly present.”

This absence, added to the knowledge that breast milk is the optimal infant diet, can act as a spur for scientific exploration, inspiring ingredient suppliers to produce these oligosaccharides as potential novel ingredients for infant nutrition.

Building up beneficial bacteria is a prime focus for DuPont Nutrition & Health (Madison, WI). Peggy Steele, global business director for probiotics, identifies the following as the company’s three major products for infant nutrition: HOWARU brand Rhamnosus (Lactobacillus rhamnosus HN001); HOWARU Bifido (Bifidobacterium lactis HN019); and Bifidobacterium lactis Bi-07.

“Infants need healthy bacteria to help colonize their gut,” says Steele. “These DuPont Danisco probiotic strains have been shown in infants to improve intestinal function, immune system development, and reduce the incidence and severity of allergies.”

Children today, even infants, are faced with daily challenges, including day care, antibiotics, and poor diet, says Steele. This gives urgency to seizing what she calls “an opportunity in early life-a window of opportunity-for reducing risk and improving overall health.”

Noting a trend towards incorporation of more functional ingredients in infant formula, Steele reports that DuPont has several studies underway related to immune and digestive health. Efforts are being put forth to improve ingredient stability as well as to uncover the how and why of probitotics mechanisms.

Though she doesn’t identify the ongoing research, Steele cites a 2008 study (Wickens et al.), in which Lactobacillus rhamnosus HN001 was effective at reducing both the incidence and severity of eczema when consumed over the first two years of life. A follow-on study has shown these benefits persisted more than two years later, she says.

Reece Prewett, director of formulated foods for Fonterra (Auckland, New Zealand), which has been manufacturing infant formula for more than 55 years, says the firm’s leading infant nutrition efforts are in probiotics, hydrolysates, and dairy complex lipids.

Prewett’s colleague, research and development manager Robert Norris says his firm’s two principal products in this field are Lactobacillus rhamnosus HN001 (trademarked as DR20) and Bifidobacterium animalis subspecies lactis HN019 (trademarked as DR10). Citing the 2008 Wickens study on HN001, which involved 425 infants, Norris says results of a six-year follow-up trial could be available later this year.

Turning to the HN019 strain, Norris calls up a 2010 study led by Sunil Sazawal, PhD, a visiting professor at Annamalai University in New Delhi, India. In this randomized, double-masked, controlled trial, published in the Journal of Pediatric Gastroenterology and Nutrition, researchers discovered that infants given DR10 with GOS showed a reduction in the risk of infection, as well as a decrease in the risk of anemia and iron deficiency.

With regard to hydrolysates, Norris says, “During the first 12 months of life, formula-fed infants can experience a number of symptoms that may be attributed to infant formula and intolerance. One solution to these challenges is to substitute the protein in infant formula with hydrolysates, which are thought to be easier to digest.” Moving on, he suggests adding dairy complex lipids to formula because they are among the closest compositional equivalents to human milk complex lipids.

Norris says that Fonterra has been involved in research to substantiate this hypothesis for more than a decade. An example of these studies is a 2012 clinical trial demonstrating that Fonterra’s Ganglioside 600 (G600) complex lipid supports brain development and learning ability in infants. The study, led by Dida Akhmad Gurnida, was conducted in Bandung, Indonesia.

The Acids Test

Echoing the sentiments of other sources-that breastfeeding is the best method of feeding infants-Cassie France-Kelly, director of corporate communications for Martek Biosciences (Columbia, MD), says, “The industry’s goal has been to continually improve the quality of formula for infants who cannot or will not be exclusively breastfeed. We believe that our ingredients, such as vitamins, lutein, zeaxanthin, and DHA and arachidonic acid (ARA) oils help achieve this goal.”

Research supporting the benefits of DHA and ARA continues to emerge, says France-Kelly. She cites a study, published in the June 2013 issue of the American Journal of Clinical Nutrition. In the study, six-year-old children who received these fatty acids during infancy-via supplemented infant formula-were faster at processing certain kinds of information, compared to children who received non-supplemented formula.

According to the study’s lead author Peter Willatts, a senior lecturer at the University of Dundee in the United Kingdom, it is generally accepted that babies require long-chain polyunsaturated fatty acids for proper brain development. The current study and others like it are important, he says, because they show that the benefits are still kicking in long after infancy.

This was true even though the sample came from a relatively divergent geographical area. Willatts reports that there were three groups of 70 children from several European countries. All were followed for four months during their infancy. One group had been given formula supplemented with DHA and ARA, a second group received straight formula (no supplements), and the last was breastfed.

When the children were tested more than five years later, both formula groups were about equal in general intelligence, but those who received DHA and ARA as infants were able to process information 20% quicker-particularly when it came to a picture-matching game. In fact, the supplemented subjects were faster than even those who had been breastfed.

France-Kelly also points to another study, published in June in Maternal & Child Nutrition. The authors, William Day Lassek, MD, and Steven J.C. Gaulin, PhD, concluded, “This study suggests that a country’s balance of dietary omega-3 and omega-6 fatty acids-as reflected in maternal milk DHA-is strongly related to its students’ performance on a standardized mathematics test. The observed relationship between milk DHA and cognitive performance remains highly significant even when controlling for national wealth, investment in education, and macronutrient intake.”

Harry Rice, PhD, vice president of regulatory and scientific affairs for the Global Organization for EPA and DHA Omega-3 (GOED; Salt Lake City), is another voice singing the praises of mother’s milk. His comments, however, give more attention to the mother and her health.

“An infant’s nutritional status is dependent upon the nutrition received in utero as well as once delivered,” he says. “The developing fetus receives DHA from the mother through the placenta during pregnancy. Pregnancy is associated with a reduction in DHA levels in the mother. Since the production of DHA in the fetus and placenta is low, an adequate maternal supplementation of DHA is very important.”

Rice acknowledges that breastfeeding provides the best nourishment for an infant, but, “For those mothers unable to breastfeed or who choose not to breastfeed for any number of reasons, it’s important that infants are fed formula containing DHA. Since 2004, most infant formula sold in the United States contains DHA.”

Other Approaches

“The bar is set very high for any ingredient going into a product for infants or children. Many of the quality standards are the same as we see on the pharmaceutical side of our business,” says Richard G. Mueller, CEO of Biothera (Eagan, MN).

Describing his firm as a biotech company focused on immune health, Mueller says, “Our premier ingredient for foods, beverages and supplements is Wellmune WGP, a beta 1,3/1,6 glucan derived from a proprietary strain of yeast, which is clinically proven to boost immune cells.”

Mueller explains that when Wellmune is swallowed, it binds to innate immune cells called neutrophils, strengthening them particularly during periods of stress.

There are nine clinical studies supporting Wellmune’s performance, Mueller says. One of the most recent-released this past April at an Experimental Biology conference in Boston-was a double-blind, randomized, controlled, 28-week study in which children fed three servings per day of a product containing DHA, yeast beta glucan, and a prebiotic blend were better able to maintain respiratory health than a control group that had the same number and duration of cow’s milk servings.

Mueller says the presentation was made by Mead Johnson Nutrition (Glenview, IL), a health and nutrition manufacturer with which Biothera has an exclusive global agreement for the formulation of Wellmune WGP in infant and toddler formula. Presently, the ingredient is featured in two Mead Johnson products: Enfagrow, designed for children between one and three years old, and Enfakid, designed for children ages three to six.

For Arla Food Ingredients (Viby J, Denmark), Joyce Stefan, U.S. account manager for nutrition, says the goal is to develop new blends of milk protein fractions that can help companies “humanize” infant formulas.

According to Stefan, many formulas for newborns provide as much as 50–80% more protein than breast milk. Moreover, she says there are continuous changes in the protein content of human breast milk, while formula remains static in this regard. To deal with the situation, Arla has introduced what it calls a “staging concept.”

Pernille Hostrup, the company’s business development manager, says this approach aims at infant formulas that provide “the right nutrients in the right quantities at the right time.” The nutrient content of the product is adjusted to a baby’s natural growth and development patterns.

Stefan says Arla’s alpha-lactalbumin ingredient, Lacprodan Alpha-10, has three important functions in infant formula: 1) it can make the protein composition in a formula more similar to what is found in human milk; 2) its amino acid composition allows the protein content in infant formula to be reduced while fulfilling the amino acid requirements set by legislation; and 3) at high levels, it appears to ease digestion of infant formula.

The Arla executive says that other phospholipid sources are sometimes added to infant formula for their emulsifying properties. They also may help support cognitive performance.

But, Stefan says, “Only dairy phospholipids-like our Lacprodan PL-20 and Lacprodan MFGM-10 ingredients-provide the same phospholipid profile found in human milk.”

And, she emphasizes, “Human milk is a very dynamic substance that changes in composition frequently from very early lactation onwards.” Staging, Stefan says, utilizes ingredients that reflect the “true dynamics” of human milk.

Scientists at Duke University also have investigated the possibility of making cow’s milk formula more “human.” In August 2012, Nutritional Outlook reported on a study in which a team led by William Parker, PhD, an associate professor of surgery, attempted to assess how milk and infant formula might interact with the immune system.

The researchers inoculated samples of breast milk, infant formula (milk-based and soy-based), cow’s milk, and an abundant antibody in breast milk, secretory immunoglobulin A (SIgA), with two strains of E. coli. Although bacteria quickly multiplied in all the specimens, there was a significant difference in how they grew in the breast milk. Here, they formed biofilms-thin, adherent layers of bacteria that could act as a shield against pathogens and infections. No such biofilm barriers appeared in the cow’s milk and formula samples. The results were mixed regarding the SIgA sample, indicating that the antibody alone wasn’t sufficiently protective.

Parker said, at the time, that the findings might help product developers explore a new approach to making infant formula that is closer to breast milk.

Volume and Trends

Despite, or perhaps because of, recognition on the part of many scientists, marketers, and consumers that breast milk is better for babies than formula, the formula market segment continues to push forward with new product launches.

Natalie Tremellen, market analyst for consulting firm Innova Market Insights, reported a 168% increase in global baby formula launches from 2011 to 2012, with Asia being the most active region. For the United States, a 5% increase in baby formula/milk launches was recorded in 2012.

Meanwhile, Robert S. McQuate, PhD, CEO and cofounder of the consulting firm GRAS Associates (Bend, OR), calls attention to the actions of several companies developing ingredients similar to those found in human milk. “Some of these may favorably impact infant health and well-being by helping to control various maladies,” he says.

To the extent that these products succeed, babies worldwide will be healthier than ever, and the industry-which is already strong-will be even more deserving of its prosperity.