Adequacy and safety of an infant formula with a protein/energy ratio of 1.8 g/100 kcal and enhanced protein efficiency for term infants during the first 4 months of life.
OBJECTIVE
Excess protein in infant formula may lead to renal overload and play a role in later obesity. The objective of this controlled, prospective, randomized, double-blind study was to assess the suitability and safety of a modified protein content infant formula and its noninferiority as compared to a conventional formula.


METHODS
Healthy term infants age < 7 days were either breast-fed or randomized to be fed exclusively with a conventional casein-predominant formula (protein/energy ratio: 2.6 g/100 kcal) or the isocaloric whey-predominant study formula (protein/energy ratio: 1.8 g/100 kcal) for 120 days. Primary outcome was daily weight gain between D0 and D120 (noninferiority criterion: difference in daily weight gain < or = 4 g). Secondary outcomes were daily gain in weight, length, head circumference and body mass index at monthly intervals. Tolerance and safety were assessed at each visit.


RESULTS
162 infants were enrolled, 84% of the formula-fed infants and 36% of the breast-fed infants completing the study. Mean daily weight gain from D0 to D120 in the formula-fed groups differed by 0.38 g/day [95% CI: -2.59; 1.83] signifying the noninferiority of the study formula. Secondary outcomes did not differ between the 2 groups at any time and were comparable to outcomes in the breast-fed group. Tolerance was good and adverse events were not different between study groups.


CONCLUSIONS
The whey-predominant study infant formula with a protein/energy ratio of 1.8 g/100 kcal and enhanced protein efficiency is safe and not inferior to a conventional formula in ensuring normal growth during the first four months of life.
Turck
Dominique
D
Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Lille University Children's Hospital and Faculty of Medicine, Lille, France. dturck@chru-lille.fr
Grillon
Christophe
C
Lachambre
Emmanuelle
E
Robiliard
Patrick
P
Beck
Laurence
L
Maurin
Jean-Luc
JL
Kempf
Christian
C
Bernet
Jean-Paul
JP
Marx
Jacques
J
Lebrun
Françoise
F
Van Egroo
Louis-Dominique
LD
D000886:Anthropometry; D001724:Birth Weight; D015992:Body Mass Index; D001942:Breast Feeding; D002364:Caseins / Q000008:administration & dosage; D004044:Dietary Proteins / Q000009:adverse effects* / Q000032:analysis*; D004311:Double-Blind Method; D002149:Energy Intake; D005260:Female; D005865:Gestational Age; D006801:Humans; D041943:Infant Formula / Q000737:chemistry*; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D008297:Male; D008894:Milk Proteins / Q000008:administration & dosage; D011446:Prospective Studies; D015430:Weight Gain; D000067816:Whey Proteins
D002364:Caseins; D004044:Dietary Proteins; D008894:Milk Proteins; D000067816:Whey Proteins