title: 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.
abstract: 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.
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Lille University Children's Hospital and Faculty of Medicine, Lille, France. dturck@chru-lille.fr
authors.forename: Dominique
authors.initials: D
authors.lastname: Turck
authors.forename: Christophe
authors.initials: C
authors.lastname: Grillon
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Lachambre
authors.forename: Patrick
authors.initials: P
authors.lastname: Robiliard
authors.forename: Laurence
authors.initials: L
authors.lastname: Beck
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Maurin
authors.forename: Christian
authors.initials: C
authors.lastname: Kempf
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Bernet
authors.forename: Jacques
authors.initials: J
authors.lastname: Marx
authors.forename: Françoise
authors.initials: F
authors.lastname: Lebrun
authors.forename: Louis-Dominique
authors.initials: LD
authors.lastname: Van Egroo
mesh_terms: 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
chemical_list: D002364:Caseins; D004044:Dietary Proteins; D008894:Milk Proteins; D000067816:Whey Proteins