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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.
J Pediatr Gastroenterol Nutr. 2006 Sep; 43(3):364-71.JP

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.

PATIENTS AND 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+Show Affiliations

Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Lille University Children's Hospital and Faculty of Medicine, Lille, France. dturck@chru-lille.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16954961

Citation

Turck, Dominique, et al. "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." Journal of Pediatric Gastroenterology and Nutrition, vol. 43, no. 3, 2006, pp. 364-71.
Turck D, Grillon C, Lachambre E, et al. 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. J Pediatr Gastroenterol Nutr. 2006;43(3):364-71.
Turck, D., Grillon, C., Lachambre, E., Robiliard, P., Beck, L., Maurin, J. L., Kempf, C., Bernet, J. P., Marx, J., Lebrun, F., & Van Egroo, L. D. (2006). 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. Journal of Pediatric Gastroenterology and Nutrition, 43(3), 364-71.
Turck D, et al. 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. J Pediatr Gastroenterol Nutr. 2006;43(3):364-71. PubMed PMID: 16954961.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Turck,Dominique, AU - Grillon,Christophe, AU - Lachambre,Emmanuelle, AU - Robiliard,Patrick, AU - Beck,Laurence, AU - Maurin,Jean-Luc, AU - Kempf,Christian, AU - Bernet,Jean-Paul, AU - Marx,Jacques, AU - Lebrun,Françoise, AU - Van Egroo,Louis-Dominique, PY - 2006/9/7/pubmed PY - 2006/10/14/medline PY - 2006/9/7/entrez SP - 364 EP - 71 JF - Journal of pediatric gastroenterology and nutrition JO - J Pediatr Gastroenterol Nutr VL - 43 IS - 3 N2 - 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. PATIENTS AND 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. SN - 1536-4801 UR - https://www.unboundmedicine.com/medline/citation/16954961/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_ L2 - https://doi.org/10.1097/01.mpg.0000228113.29359.b1 DB - PRIME DP - Unbound Medicine ER -