Blueberry Intake and Infant Gut Health

Not Applicable

Recruiting

• Conditions: Infant Development
• Interventions: Other: Placebo Powder; Other: Blueberry Powder

• Registration Number: NCT05006989
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-16
• Study Start: 2021-09-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Powder	Participants will be provided placebo powder to be consumed.
Intervention Group	Blueberry Powder	Participants will be provided pre-made whole blueberry freeze-dried powder to be consumed.

Primary Outcome Measures

Name	Time	Method
Infant Growth (Length)	Over 7 months	Measured in cm
Serum sCD14 (Soluble CD14)	Over 7 months	Measured in µg/mL
Fecal Calprotectin	Over 7 months	Measured in µg/g
Dietary Intake	Over 7 months	3 day dietary recall with results generated by NDSR software
Serum AGP (Alpha-1-Acid Glycoprotein)	Over 7 months	Measured in mg/mL
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 (Weight)	Over 7 months	Measured in kg
Serum hsCRP (High-Sensitivity C-Reactive Protein)	Over 7 months	Measured in mg/L
Serum TNF-α (Tumor Necrosis Factor alpha)	Over 7 months	Measured in pg/mL

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States