Effect of Milk-Based Infant Formula Fortified with PUFAs on Lipid Profile, Growth and Micronutrient Status of Young Children: A Randomized Double-Blind Clinical Trial.

BACKGROUND: Polyunsaturated fatty acids (PUFAs) are essential to child growth and development. OBJECTIVE: To assess the effect of PUFAs-fortified infant formula on lipid profile, growth and micronutrient status in children 12 to 30 months old. METHODS: This study is a double-blind randomized controlled clinical trial. Two study groups were assessed: (a) milk-based infant formula with micronutrients and PUFAs (PUFAs) and (b) milk-based infant formula with micronutrients, no PUFAs added (Non-PUFAs). Children received prepared formula (240 mL) twice a day, according to the color-code assigned to each infant. Anthropometric measurements and venous blood samples were taken at each day-care center at baseline, and again after four months. Total serum lipid extraction was 0.5 mL. Samples were treated and modified by the Folch method and analyzed with gas chromatography. RESULTS: Changes in serum lipid profile (expressed as % FA) between baseline and four months showed a statistically significant increase in docosahexaenoic acid (DHA) (0.22 vs. -0.07, p < 0.05) and Alpha-Linoleic acid (0.08 vs. 0.02, p < 0.05) in infants who consumed PUFAs-fortified formula compared to Non-PUFAs-fortified formula. Infants increased their length/height-for-age Z-score: median change for the PUFAs group was 0.16 (95% CI = 0.08, 0.28) and 0.23 (95% CI = 0.14, 0.33) for Non-PUFAs, with no differences between groups. Median folate level was significantly higher among the PUFAs group compared to Non-PUFAs: -0.87 (95% CI = -1.38, -0.44) and -3.83 (95% CI = -4.65, -3.03) respectively. Consumption of both supplements was adequate and stable during the intervention. CONCLUSION: A significant improvement was observed in the lipid profile of children who received the PUFAs-fortified milk-based formula.