(P22-018-23) Study Protocol of a Double-Blind, Randomized Controlled Trial To Determine the Effects of Blueberry on Gut Microbiota, Inflammation and Innate Immunity in Weaning Infants

Objectives: Research in adults and animal models showed that blueberry attenuates inflammation and promotes commensal growth in the gut. This study will test the effect of blueberry, as a first food for weaning breastfed infants, on gut microbiota, inflammation, and innate immunity development.

Methods: This is a double-blind, randomized, placebo-controlled trial. Seventy-six breastfed infants from Denver, Colorado metro area will be recruited and enrolled at ~5 months of age and randomized to a blueberry group (n=38, 10 g/day freeze-dried blueberry powder) or a placebo group (n=38, 10 g/day placebo powder) until 12 months of age. Randomization is stratified by sex and mode of delivery (vaginal or C-section). Participants’ breastmilk and solid food intakes are not restricted. Baseline (~5 months) and end of study visits (12 months) take place at Children’s Hospital Colorado, and anthropometric measurements (weight, length, head circumference), a three-day diet record, and blood and stool samples will be collected. Family demographics and health history forms will also be filled out. Home visits will be conducted at 7, 9 and 11 months to collect anthropometrics, diet records, health history, and stool samples. Blueberry or placebo powders and study supplies are also delivered at home visits. Blood samples will be used to measure inflammatory and innate immunity biomarkers. Stool samples will be used to measure gut microbial composition via 16S rRNA sequencing.

Results: N/A (protocol abstract)

Conclusions: Findings will provide evidence of blueberry’s impact on gut microbiota colonization, inflammatory responses, and innate immunity development in weaning infants to possibly inform dietary recommendations during complementary feeding.

Funding Sources: The U.S Highbush Blueberry Council