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
| Autor: | Christian Kempf, L. Beck, Jean-Paul Bernet, E. Lachambre, Jean-Luc Maurin, Patrick Robiliard, Louis-Dominique Van Egroo, Jacques Marx, Françoise Lebrun, Christophe Grillon, Dominique Turck |
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| Rok vydání: | 2006 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Gestational Age Weight Gain Body Mass Index Double-Blind Method Birth Weight Humans Medicine Prospective Studies Infant Nutritional Physiological Phenomena Adverse effect Lead (electronics) Anthropometry business.industry Infant Newborn Gastroenterology Caseins A protein Milk Proteins medicine.disease Obesity Infant Formula Breast Feeding Whey Proteins Infant formula Pediatrics Perinatology and Child Health Female Dietary Proteins medicine.symptom Energy Intake business Breast feeding Weight gain Body mass index |
| Zdroj: | Journal of Pediatric Gastroenterology & Nutrition. 43:364-371 |
| ISSN: | 0277-2116 |
| DOI: | 10.1097/01.mpg.0000228113.29359.b1 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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