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The Penguin Study: A Randomised, Double-Blinded, Equivalence Trial on the Safety and Suitability of an Infant Formula
Lindsey Otten1, Antonia Nomayo1, Caroline Gunn2
1Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstraße 555, 13589 Berlin, Germany.
Insights
Partially hydrolysed whey protein (PHF) infant formula is safe and supports adequate growth, showing non-inferior weight gain compared to standard intact protein formula (IPF) in healthy term infants.
Area of Science:
- Nutritional Science
- Pediatrics
- Gastroenterology
Background:
- Infant formula composition is critical for growth and safety.
- Partially hydrolysed whey protein (PHF) formula offers a potential alternative to standard intact protein formula (IPF).
Purpose of the Study:
- To evaluate the safety and suitability of PHF infant formula.
- To compare PHF with standard IPF in healthy term infants.
Main Methods:
- Multicentre, randomised, double-blinded, placebo-controlled trial.
- Infants received PHF or IPF for 90-180 days; a breastfed group served as reference.
- Safety assessed via weight gain equivalence, growth parameters, and adverse events.
Main Results:
- Mean daily weight gain was comparable between PHF and IPF groups, within equivalence margins.
- No significant differences observed in weight gain, length, head circumference, or adverse events.
- Growth patterns in both formula groups were comparable to the breastfed reference group.
Conclusions:
- Partially hydrolysed whey protein (PHF) infant formula is safe for healthy term infants.
- PHF supports adequate infant growth, demonstrating non-inferior weight gain compared to standard intact protein formula (IPF).
Abstract:
Background/Objectives: This study aimed to demonstrate the safety and suitability of an infant formula manufactured from partially hydrolysed whey protein (PHF) compared to standard formula manufactured from intact cow's milk proteins (IPF; whey-casein ratio, 60:40) in healthy term infants. Methods: This multicentre, randomised, double-blinded, placebo-controlled trial included infants of mothers who intended to exclusively formula feed. Infants ≤ 28 days of age received PHF or IPF for at least 90 and up to 180 days. A group of exclusively breastfed infants was included for reference. The safety evaluation consisted of an equivalence analysis of weight gain within +/-3 g/d after 90 days, further growth parameters, and adverse events. Results: Of the 249 infants randomised, 143 (76 IPF; 67 PHF), as well as 45 breastfed infants, completed the study per protocol. The mean difference in daily weight gain between the formula groups was within the equivalence margins (-2.4 g/d (95% CI 0.3-4.5)) with estimated means (SEM) of 34.9 (0.78) g/d (IPF) and 32.5 (0.76) g/d (PHF). No significant differences in weight gain, length, and head circumference or in the number, severity, or type of adverse events were observed. Comparable growth patterns were observed in the breastfed group. Conclusions: The PHF is safe and supports adequate infant growth with a daily weight gain non-inferior to a standard IPF.
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