Alpha-lactalbumin-rich infant formula fed to healthy term infants in a multicenter study: plasma essential amino acids and gastrointestinal tolerance.
OBJECTIVE
To evaluate the efficacy and safety of an alpha-lactalbumin-enriched formula with a protein profile and total protein concentration closer to human milk (HM) and lower than conventional formulas.


METHODS
Two hundred and sixteen healthy, term infants, <or=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).


CONCLUSIONS
The study demonstrated that feeding a higher quality, lower protein concentration formula (alpha-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.
Wyeth Nutrition, Collegeville, PA 19426, USA.
A M
AM
Davis
B J
BJ
Harris
E L
EL
Lien
K
K
Pramuk
J
J
Trabulsi
D000601:Amino Acids, Essential / Q000097:blood*; D004044:Dietary Proteins / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage / Q000737:chemistry*; D007227:Infant Nutritional Physiological Phenomena / Q000502:physiology*; D007231:Infant, Newborn / Q000097:blood* / Q000254:growth & development*; D007768:Lactalbumin / Q000008:administration & dosage*; D008297:Male; D008895:Milk, Human / Q000737:chemistry; D009751:Nutritional Requirements; D011446:Prospective Studies; D015430:Weight Gain
D000601:Amino Acids, Essential; D004044:Dietary Proteins; D007768:Lactalbumin