Pfizer study supports lutein safety for infant formula

By Stephen Daniells

- Last updated on GMT

Related tags Infant formula Breastfeeding Milk

The inclusion of lutein into infant formula is safe and does not affect growth in the infants, according to a new study from Pfizer Nutrition.

Infant formula is a highly emotive area, with watchdogs keeping a close eye on companies' marketing tactics lest they drift towards promoting their products as preferable to breast-feeding.

While it is agreed that breastfeeding is the best way to ensure an infant receives the nutrients it needs in its first months, formulas are indispensable in cases where mothers are unable to feed their children - be it for health or logistical reasons. Mothers' desire to give their children the best possible start in life means that there is scope for fortification.

According to the new study, funded entirely by Pfizer (formerly Wyeth Nutrition), the lutein content of breast milk varies by country, with a recent survey showing the highest levels in China (of about 230 micrograms per litre) and the lowest levels in the UK (of about 3 micrograms per litre).

“These carotenoids are currently not added to infant formula, which has a small and variable innate amount of lutein,”​ stated the researchers in the Nutrition Journal​.

Led by Pfizer’s Bruce Harris, the scientists recruited 232 infants and randomly assigned them to receive either a control formula (Wyeth S-26 Gold) or an experimental formula with additional lutein at a level of 200 micrograms per litre. The lutein used in the study was from Kemin.

After 16 weeks of intervention, the scientists report that 220 infants completed the study. Both groups demonstrated “appropriate growth”, said the researchers, with no significant differences between the groups.

Harris and his co-workers also note that both study formulas were well tolerated.

“From the data in this study, lutein fortification of S-26 Gold at 200 micrograms per litre is safe and allows normal infant growth,”​ concluded the researchers.

Lutein facts

Lutein, a nutrient found in various foods including green leafy vegetables and egg yolk, has a ten-year history in the dietary supplement market as a nutrient to reduce the risk of age related macular degeneration (ADM). It is often used in combination with zeaxanthin.

The global lutein market is set to hit $124.5 million (€93 million) in 2013, according to a 2007 report from Frost & Sullivan.

The findings support the previous conclusions of the European Food Safety Authority (EFSA) from 2008, which deemed lutein safe for use in infant formula in doses up to 250-300mg/l and 500mg/l in follow-on formula.

The study scientists were affiliated with the Asian Hospital and Medical Center in the Philippines, Wyeth Philippines, Martek, and Pfizer (formerly Wyeth) Nutrition.

Source: Nutrition Journal
2010, 9​:22 doi: 10.1186/1475-2891-9-22
“Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety”
Authors: R. Capeding, C.P. Gepanayao, N. Calimon, J. Lebumfacil, A.M. Davis, N. Stouffer, B.J. Harris

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