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A Randomized Controlled Trial Assessing Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula Compared
David Fields1, Laura Czerkies2, Shumei Sun3
1University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Insights
A hypoallergenic whey-based extensively hydrolyzed formula (EHF) with Bifidobacterium lactis supported healthy infant growth, showing higher weight gain and fewer digestive issues compared to a casein-based EHF.
Area of Science:
- Pediatric Nutrition
- Infant Growth and Development
- Gastroenterology
Background:
- Extensively hydrolyzed formulas (EHFs) are used for infants with cow's milk allergy.
- The composition of EHFs, including protein source and added probiotics, may influence infant growth and tolerance.
- Limited data exists comparing whey-based vs. casein-based EHFs with probiotics in healthy infants.
Purpose of the Study:
- To compare the growth and tolerance of healthy infants fed a whey-based EHF with Bifidobacterium lactis versus a casein-based EHF.
- To evaluate anthropometric measurements, stool characteristics, and adverse events in both formula groups.
Main Methods:
- Randomized controlled trial involving 282 healthy infants (14 ± 3 days old).
- Infants were assigned to receive either a test (whey-based EHF with Bifidobacterium lactis) or control (casein-based EHF) formula until 112 days of age.
- Anthropometric data, stool frequency/consistency, and adverse events were systematically recorded. Serum albumin and plasma amino acids were assessed in a subset.
Main Results:
- The test group exhibited significantly higher mean daily weight gain (27.95 g/d vs. 25.93 g/d) and fewer stools (2.2/d vs. 3.6/d) compared to the control group.
- The control group experienced more days with loose stools and a higher incidence of vomiting.
- Fewer infants in the test group dropped out (41%) compared to the control group (56%). Adverse events were more frequently attributed to the control formula.
Conclusions:
- A hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF) containing Bifidobacterium lactis supports healthy infant growth.
- This whey-based EHF demonstrates improved tolerance, evidenced by better weight gain and reduced gastrointestinal symptoms compared to a casein-based EHF.
- Further research into this formula's application in clinically indicated populations is recommended.
Abstract:
This study compared the growth of healthy infants fed a hypoallergenic 100% whey-based extensively hydrolyzed formula (EHF) with Bifidobacterium lactis (test) with that of infants fed an extensively hydrolyzed casein formula (control). Formula-fed infants (14 ± 3 days) were randomized to test or control groups until 112 days of age. Anthropometrics were assessed at 14, 28, 56, 84, and 112 days, and daily records were kept for 2 days prior to study visits. Serum albumin and plasma amino acids at 84 days were assessed in a subset. A total of 282 infants were randomized (124 test, 158 control). Significantly more infants dropped out of the control (56%) as compared with the test (41%) group. Mean daily weight gain was significantly higher in the test group compared with the control group (27.95 ± 5.91 vs 25.93 ± 6.12 g/d; P = .027) with the test group reporting significantly fewer stools (2.2 vs 3.6 stools/d; P < .0001). The control group reported significantly more days with >3 loose stools/d and a higher incidence of vomiting as compared with the test group. There were no differences in gas, mood, sleep, or serum albumin. Plasma arginine and valine were significantly lower in the test group, whereas leucine and lysine were higher; all values were within normal limits. Significantly more adverse events attributed to the study formula were reported in the control group. The 100% whey-based hypoallergenic EHF containing Bifidobacterium lactis and medium chain triglycerides supported growth of healthy infants. Future studies on the application of this formula in clinically indicated populations are warranted.
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