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[Tolerance and adequacy of a 100% lactose infant formula. A controlled randomized double-blind study]
J-P Girardet1, V Fournier, P Bakhache
1Gastroentérologie et nutrition pédiatrique, hôpital Armand-Trousseau, AP-HP, université Pierre-et-Marie-Curie - Paris-6, 26, avenue du Docteur-Arnold-Netter, 75012 Paris, France. jean-philippe.girardet@trs.aphp.fr
A new infant formula using 100% lactose demonstrated safety and efficacy, supporting normal infant growth comparable to conventional formulas. This lactose-based formula supports healthy development in early infancy.
Area of Science:
- Nutritional Science
- Pediatric Nutrition
- Gastroenterology
Context:
- Lactose is a key carbohydrate in breast milk, offering nutritional benefits for infants.
- Conventional infant formulas often contain lactose and maltodextrin.
- The role of carbohydrate composition in infant formula is critical for development.
Purpose:
- To evaluate the safety and adequacy of an infant formula exclusively using lactose as the carbohydrate source.
- To compare the growth and safety outcomes of a 100% lactose formula against a standard formula in healthy infants.
- To determine the non-inferiority of a 100% lactose infant formula in terms of daily weight gain.
Summary:
- A randomized, double-blind study involving 178 healthy infants compared a 100% lactose formula with a conventional formula over 120 days.
- Results showed the 100% lactose formula was non-inferior in promoting daily weight gain (0.71 g/day difference).
- Both formulas supported normal growth, with good tolerance and similar adverse event profiles, though energy and protein intake were lower with the 100% lactose formula.
Impact:
- The study confirms that a 100% lactose infant formula is a safe and effective alternative to conventional formulas for supporting infant growth.
- Findings support the use of lactose as the sole carbohydrate source in infant formulas, potentially simplifying composition.
- This research contributes to understanding optimal carbohydrate sources for infant nutrition and formula development.
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