Growth and Tolerance Assessment of a Lutein-fortified Infant Formula

Abstract

PurposeTo evaluate safety, gastrointestinal tolerance, and growth of a new experimental starter formula (NESF) fortified with lutein, prebiotics, probiotics, nucleotides and beta-carotene, fed to infants within the first months of life.MethodsThis was a non-randomized, open, uncontrolled study conducted from December 2010 to May 2011. Twenty-three healthy infants aged 10 days to 2 months old were enrolled. Outcomes included gastrointestinal tolerance, physical growth and safety. Prior to the initiation of the trial, the Scientific Research Institute of Nutrition of the Russian Academy of Medical Sciences confirmed that the NESF met all safety and nutritional parameters.ResultsNESF was well tolerated. The majority of infants fed this formula passed semi-liquid, yellow or yellow-brown. The mean stool frequency/day was 2.5±0.4 on study-day 14 and 1.8±0.5 on study-day 28. The mean daily weight gain was 30.9±3.8 grams and the mean length gain during the 28 days of follow up was 3.1±0.8 cm, corresponding to the average physical growth normally seen in the first months of life in Russian infants. Six children left the study: one refused to drink the formula, one left the study as parents changed residence; and one child's parents have recalled their informed consent due to adverse event unrelated to the product. Three infants presented adverse events possibly related to the product (rash; colic and abdominal pain; constipation). Seventeen infants completed the trial.ConclusionThis study demonstrated that lutein-fortified formula is safe, well-tolerated and supported physical growth of evaluated infants.

Nutritional Gaps and Supplementation in the First 1000 Days

“…There is very little information for healthcare providers to help guide mothers in their post-birth recovery or their nutritional transition to motherhood. Multiple studies have supplemented infants with lutein and zeaxanthin, demonstrating these nutrients are safe and effective in increasing plasma concentrations of lutein and zeaxanthin and reducing oxidative stress and inflammation [260][261][262][263][264][265][266]. Plasma lutein levels in infants have been shown to correlate with the saturated response amplitude in rod photoreceptors, suggesting that lutein helps protect photoreceptors and potentially impacts retinal development through its ability to reduce inflammation [266].…”

Biotechnological Production of Carotenoids and Their Applications in Food and Pharmaceutical Products

“…The French cheese named vieux-pan contains the carotenoid produced by Brevibacterium linens due to its orange-red-brown color that improves the sensory quality of the product [70]. In Russia, infant formulas are enriched with natural pigments such as lutein, which is present in breast milk, in order to improve children's health [71].…”

<p>Insights into Novel Infant Milk Formula Bioactives</p>

“…60 It functions as a structural component of the eye, an antioxidant, and as a filter for blue light. Lutein plays a biological and physiological role in the visual development and function in infants; 61 and infants are reliant on breastfeeding to receive adequate quantities. 62 Differences in serum lutein content between breastfed and formula-fed infants are seen as early as 1 month of age.…”

“…63 Recent studies demonstrated that lutein-supplemented infant formula is safe and supports the visual and cognitive development of infants. [60][61][62]64 Presently, there is no research that lutein supplementation influences brain accretion during infancy. A recent study found that the concentration of lutein is higher in several regions of the brain during infancy than in adulthood which may indicate that lutein may play an important role in early neural development.…”

“…However, further research on lutein must be conducted to ensure efficacy for optimal growth and development outcomes in infants. 61…”