Infant Development
Conditions
Keywords
Blueberries, Gut microbiota, Inflammation, Innate immunity, Early complementary feeding
Brief summary
The objective of this project is to investigate the effects of blueberries on gut microbiota, inflammation and innate immunity in breastfed infants during early complementary feeding (\ 5 to 12 months of age).
Detailed description
Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.
Interventions
OTHERBlueberry Powder
Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.
OTHERPlacebo Powder
Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.
Sponsors
U.S. Highbush Blueberry Council
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Months to 5 Months
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy * Full term (gestational age ≥ 37 weeks) * No prior exposure of solid foods * Exclusively breastfed (\< 2 weeks of cumulative formula exposure) * Willing to consume blueberry/placebo powder
Exclusion criteria
* Having health conditions that would affect normal growth * Pre-term * Consumed formula for more than two weeks * Not willing to consume the blueberry/placebo powders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing | Over 7 months | 16S rRNA amplicon sequencing is used to profile taxonomic makeup of fecal specimens. Within the gut microbiome composition, microbial diversity will be summarized using common ecological measures (Good's coverage, Sobs, and Shannon alpha diversity). |
| Infant Growth (Length) | Over 7 months | Measured in cm |
| Infant Growth (Weight) | Over 7 months | Measured in kg |
| Dietary Intake | Over 7 months | 3 day dietary recall with results generated by NDSR software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis | Over 7 months | Metabolomics analysis (nutri-metabolomics) is used to identify and validate food-derived biomarkers that may be classified as biomarkers of intake and/or biomarkers of effect, both of which can be linked to health indicators. |
Countries
United States
Outcome results
None listed