Blueberry Intake and Infant Gut Health

Infant Development Clinical Trial

Official title:

Blueberry Intake and Infant Gut Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05006989
• Other study ID #: 20-1659
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2023

Study information

• Verified date: February 2023
• Source: University of Colorado, Denver
• Contact: Minghua Tang, PhD
• Phone: 303-724-3248
• Email: minghua.tang[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Development

Intervention

Other:
• Blueberry Powder
Administered 10 grams/day
• Placebo Powder
Administered 10 grams/day

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	U.S. Highbush Blueberry Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing	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).	Over 7 months
Primary	Infant Growth (Length)	Measured in cm	Over 7 months
Primary	Infant Growth (Weight)	Measured in kg	Over 7 months
Primary	Dietary Intake	3 day dietary recall with results generated by NDSR software	Over 7 months
Primary	Serum hsCRP (High-Sensitivity C-Reactive Protein)	Measured in mg/L	Over 7 months
Primary	Serum TNF-a (Tumor Necrosis Factor alpha)	Measured in pg/mL	Over 7 months
Primary	Serum AGP (Alpha-1-Acid Glycoprotein)	Measured in mg/mL	Over 7 months
Primary	Serum sCD14 (Soluble CD14)	Measured in µg/mL	Over 7 months
Primary	Fecal Calprotectin	Measured in µg/g	Over 7 months
Secondary	Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis	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.	Over 7 months