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A long-term study supports the ingredient's safe use in formula.
Inulin may allow infant formula to more closely mimic the bacterial composition of human breast milk, but health bodies have expressed concern over whether the prebiotic may cause watery stools and other adverse effects in infants. A new study on the long-term safety of inulin-enriched formula may help to quell this concern.
In a study sponsored by inulin supplier Beneo GmbH (Mannheim, Germany), university researchers analyzed the stools of 131 infants on control formula or formula with oligofructose-enriched inulin (Synergy1) from birth to four months of age. Stools were assessed for frequency, water balance, and bacterial compositions, and compared to those of 57 breastfed infants.
Infants who consumed the inulin-enriched formula experienced softer and more frequent stools than infants on control formula, but this was not associated with an impaired water balance. Adverse event reports and anthropometry parameters were no different for each group.
Diederick Meyer, PhD, is the manager of scientific and regulatory affairs for Sensus (Roosendaal, the Netherlands), another inulin supplier. He says that while health bodies have expressed concern over potential adverse effects of inulin in formula, they have still gone ahead and cleared some ingredients for this use. The EU approved a long-chain inulin for formula use years ago, and FDA recently had no questions in response to a Beneo GRAS application for formula-intended oligofructose.
“Also, data for other prebiotic ingredients show that they may have a positive effect on the fecal flora composition of infants of various ages without adverse effects,” says Meyer. “As an example, native Frutafit inulin from Sensus was tested in infants with average 13 weeks and 8 months, showing a bifidogenic effect without significant adverse effects on stool consistency.”
In the Beneo study, the bacterial profile of the inulin group’s stools more closely resembled that of breastfed infants, with a trend towards high levels of health-promoting Bifidobacteria.