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Article

Clinical Evaluation of 16-Week Supplementation with 5HMO-Mix in Healthy-Term Human Infants to Determine Tolerability, Safety, and Effect on Growth

1
Chr. Hansen HMO GmbH, 53619 Rheinbreitbach, Germany
2
Chr. Hansen A/S, 2970 Hoersholm, Denmark
3
Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), 52074 Aachen, Germany
*
Author to whom correspondence should be addressed.
Academic Editor: Nadja Haiden
Nutrients 2021, 13(8), 2871; https://doi.org/10.3390/nu13082871
Received: 25 June 2021 / Revised: 16 August 2021 / Accepted: 17 August 2021 / Published: 20 August 2021
(This article belongs to the Section Pediatric Nutrition)
Human milk oligosaccharides (HMOs) are complex sugars that occur naturally in human breast milk and provide many beneficial functions. Most formula products lack HMOs or contain only the most abundant HMO, 2′-fucosyllactose; however, benefits of HMOs come from multiple sugars. We therefore developed a mixture of five HMOs (5HMO-Mix) mimicking the natural concentrations of the top five HMOs (5.75 g/L total, comprising 52% 2′-fucosyllactose, 13% 3-fucosyllactose, 26% lacto-N-tetraose, 4% 3′-sialyllactose, and 5% 6′-sialyllactose) representing the groups of neutral, neutral-fucosylated, and sialylated HMOs. We conducted the first multicenter, randomized, controlled, parallel-group clinical study assessing the safety, tolerability, and effect on growth of formula containing the 5HMO-Mix in healthy infants. We enrolled 341 subjects aged ≤14 days; 225 were randomized into groups fed either with infant formula containing 5HMO-Mix (5HMO-Mix) or infant formula without HMOs (IF) for 4 months, with the others exclusively breastfed. There were no differences in weight, length, or head circumference gain between the two formula groups. The 5HMO-Mix was well tolerated, with 5HMO-Mix and breastfed infants producing softer stools at a higher stool frequency than the control formula group. Adverse events were equivalent in all groups. We conclude that the 5HMO-Mix at 5.75 g/L in infant formula is safe and well tolerated by healthy term infants during the first months of life. View Full-Text
Keywords: 5HMO-Mix; human milk oligosaccharides; clinical study; growth; tolerability; 2′-fucosyllactose; 3-fucosyllactose; lacto-N-tetraose; 3′-sialyllactose; 6′-sialyllactose; 2′-FL; 3-FL; LNT; 3′-SL; 6′-SL 5HMO-Mix; human milk oligosaccharides; clinical study; growth; tolerability; 2′-fucosyllactose; 3-fucosyllactose; lacto-N-tetraose; 3′-sialyllactose; 6′-sialyllactose; 2′-FL; 3-FL; LNT; 3′-SL; 6′-SL
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MDPI and ACS Style

Parschat, K.; Melsaether, C.; Jäpelt, K.R.; Jennewein, S. Clinical Evaluation of 16-Week Supplementation with 5HMO-Mix in Healthy-Term Human Infants to Determine Tolerability, Safety, and Effect on Growth. Nutrients 2021, 13, 2871. https://doi.org/10.3390/nu13082871

AMA Style

Parschat K, Melsaether C, Jäpelt KR, Jennewein S. Clinical Evaluation of 16-Week Supplementation with 5HMO-Mix in Healthy-Term Human Infants to Determine Tolerability, Safety, and Effect on Growth. Nutrients. 2021; 13(8):2871. https://doi.org/10.3390/nu13082871

Chicago/Turabian Style

Parschat, Katja, Cathrine Melsaether, Kristina Rasch Jäpelt, and Stefan Jennewein. 2021. "Clinical Evaluation of 16-Week Supplementation with 5HMO-Mix in Healthy-Term Human Infants to Determine Tolerability, Safety, and Effect on Growth" Nutrients 13, no. 8: 2871. https://doi.org/10.3390/nu13082871

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