(PTFS09-01-26) Dietary Intake of Infants Fed Infant Formula With and Without 5 Human Milk Oligosaccharides at 6 and 12 Months of Age: Results From a Randomized, Controlled Trial

Objectives: To our knowledge, no clinical trials have assessed dietary intake of infants fed infant formula with human milk oligosaccharides (HMOs). This substudy of the Brain, Immune, and Gut Health study (NCT04957992) aimed to analyze the dietary intake of infants fed formula with and without 5 HMOs at 6 and 12 months of age.

Methods: Healthy, term, formula-fed infants were randomized to receive either a study formula (SF) with 2.5 g/L of 5 HMOs (2′-FL, 3-FL, LNT, 3′-SL, 6′-SL) or a matched control formula without HMOs (CF) from enrollment to 12 months. A third group of infants fed human milk were enrolled as a reference group, but human milk volume/content were not analyzed. Dietary intake included complementary foods and formula. Formula intake was estimated using 3-day intake records collected before the 6- and 12-months visits. 24-hour dietary recalls were collected at 6 and 12 months and analyzed using Food Processor (Trustwell). Group differences were assessed using repeated measures of AN(C)OVA (SAS® 9.4), with P≤0.05 considered significant.

Results: Only complete dietary recalls and biologically plausible nutrient intakes were included and analyzed at 6 (CF n=38, SF n=38) and 12 (CF n=86, SF n=96) months of age. HMO consumption from SF was 2.4-2.0 g/day at 6-12 months of age. There were no significant differences in dietary intake per day between infants fed CF and SF (LSM±SE) including for calories (1064±35 vs 1089±33 kcal, P=0.609), carbohydrates (133.54±5.29 vs 131.40±5.00 g, P=0.768), fat (47.03±1.60 vs 49.72±1.51 g, P=0.224), protein (28.28±1.54 vs 30.91±1.45 g, P=0.415), and key micronutrients such as calcium (666±26 vs 710±25 mg, P=0.365), vitamin D (9.73±0.24 vs 10.15±0.22 µg, P=0.290), and iron (15.95±1.04 vs 16.74±0.98 mg, P=0.679) at 12 months of age. There were no significant differences in percent of infants meeting the Adequate Intakes (AI) and Estimated Average Requirements (EAR) (P>0.05) with mean nutrient intakes ≥AI and not < 97% of the EAR, indicating no inadequate nutrient intake.

Conclusions: For the first time, dietary intake was assessed in infants fed a formula with HMOs through 12 months of age. The addition of 5 HMOs over the first year of life had no impact on dietary intake. These findings provide yet another outcome supporting the addition of multiple HMOs to infant formula during infancy.

Funding Sources: Abbott Nutrition