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α-Lactalbumin-rich infant formula fed to healthy term infants in a multicenter study: plasma essential amino acids and gastrointestinal tolerance

European Journal of Clinical Nutrition volume 62, pages 1294–1301 (2008)Cite this article

Abstract

Objective:

To evaluate the efficacy and safety of an α-lactalbumin-enriched formula with a protein profile and total protein concentration closer to human milk (HM) and lower than conventional formulas.

Subjects/methods:

Two hundred and sixteen healthy, term infants, ⩽14 days post-natal age were enrolled and 166 (76.9%) completed the study. Timed post-prandial plasma essential amino-acid levels were determined after 8 weeks of ad libitum study feeding. Study events were assessed every 2 weeks.

Results:

At 8 weeks, all mean plasma essential amino-acid levels in the experimental formula (EF) group were as high as the standard formula (SF) and HM groups. The incidence of feeding-related gastrointestinal (GI) events varied significantly (P=0.025) across groups: SF (31.3%), EF (17.2%) and HM (13.6%), with SF being significantly higher than HM (P=0.015). Study withdrawals due to feeding-related GI events were significantly different (P=0.001) across groups: SF (12.5%), EF (4.7%), and HM (0%). The timing of GI events was also significantly different across groups (P=0.010).

Conclusion:

The study demonstrated that feeding a higher quality, lower protein concentration formula (α-lactalbumin-enriched) met all essential amino acid and protein requirements of infants. The GI tolerance profile of infants receiving the EF was similar to HM-fed infants.

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Acknowledgements

This study was funded by a grant from Wyeth Nutrition (Collegeville, PA, USA). This study would not have been possible without the diligent work from each of the following 12 investigators and their study staff at each site: Jeffrey Adelglass, MD (Dallas, Texas); William Brown, MD (Murfreesboro, Tennessee); Gloria Durelli, MD (Stratford, New Jersey); Martin Greenberg, MD (Savannah, Georgia); Frank Hughes, MD (Bossier City, Louisiana); John A Fling, MD (Fort Worth, Texas); Cyndy Lively, MD (Winston-Salem, North Carolina); Douglas K. Mitchell, MD (Norfolk, Virginia); Kathleen Salter, MD (Chapel Hill, North Carolina); Richard Schwartz, MD (Vienna, Virginia); John Spitzer, MD (Kalamazoo, Michigan); Tracy Stewart, MD (Little Rock, Arkansas).

A special thanks to Nicole Stouffer, MS, Biostatistician consultant, and Robert Paul Felton, Biostatistician from Biotechnical Services Inc., N Little Rock, AR and Susan Troemel, BS, Wyeth, Collegeville, PA, USA, for their expert contributions.

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Authors and Affiliations

  1. Wyeth, Collegeville, PA, USA

    A M Davis, B J Harris, K Pramuk & J Trabulsi

  2. Department of Food Science and Human Nutrition, University of Illinois, Urbana, IL, USA

    E L Lien

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  1. A M Davis
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  2. B J Harris
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  3. E L Lien
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  4. K Pramuk
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  5. J Trabulsi
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Corresponding author

Correspondence to B J Harris.

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Guarantor: B Harris.

Contributors: AMD, BJH and ELL designed the study. AMD, BJH and the Multi-Center Group collected the data. AMD, BJH, ELL, KP and JT conducted data analysis and interpretation. AMD, BJH, ELL, KP and JT wrote the manuscript.

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Davis, A., Harris, B., Lien, E. et al. α-Lactalbumin-rich infant formula fed to healthy term infants in a multicenter study: plasma essential amino acids and gastrointestinal tolerance. Eur J Clin Nutr 62, 1294–1301 (2008). https://doi.org/10.1038/sj.ejcn.1602848

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