Blueberry Intake and Infant Gut Health

NCT05006989 | Completed

• 1 other identifier: 20-1659
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Infant Development

Keywords

Blueberries; Gut microbiota; Inflammation; Innate immunity; Early complementary feeding

Outcome Measures

Primary Outcomes (4)

• 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

• Infant Growth (Length)

  Measured in cm

  Over 7 months

• Infant Growth (Weight)

  Measured in kg

  Over 7 months

• Dietary Intake

  3 day dietary recall with results generated by NDSR software

  Over 7 months

Secondary Outcomes (1)

• Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis

  Over 7 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will be provided pre-made whole blueberry freeze-dried powder to be consumed.

Other: Blueberry Powder

Placebo Group

PLACEBO COMPARATOR

Placebo powder with matching color and texture.

Other: Placebo Powder

Interventions

Blueberry Powder OTHER

Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.

Intervention Group

Placebo Powder OTHER

Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.

Placebo Group

Eligibility Criteria

• Age: 4 Months - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• U.S. Highbush Blueberry Council: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Glime GNE, Matzeller KL, Frank DN, Kotter C, Kofonow JM, Robertson CE, Venter C, Campbell WW, Krebs NF, Tang M. Introducing blueberry powder as one of the first complementary foods changes the gut microbiota composition and diversity in U.S. human milk-fed infants: a double-blind, randomized controlled trial. Front Nutr. 2025 Sep 4;12:1623521. doi: 10.3389/fnut.2025.1623521. eCollection 2025.

  PMID: 40977976 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Minghua Tang, PhD

  University of Colorado Denver | Anschutz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 16, 2021
• Study Start: September 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: March 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)