Blueberry Intake and Infant Gut Health

April 25, 2025 updated by: University of Colorado, Denver
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 5 months (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants will be provided pre-made whole blueberry freeze-dried powder to be consumed.
Other: Blueberry Powder
Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.
Placebo Comparator: Placebo Group
Placebo powder with matching color and texture.
Other: Placebo Powder
Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing
Time Frame: 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).
Over 7 months
Infant Growth (Length)
Time Frame: Over 7 months
Measured in cm
Over 7 months
Infant Growth (Weight)
Time Frame: Over 7 months
Measured in kg
Over 7 months
Dietary Intake
Time Frame: Over 7 months
3 day dietary recall with results generated by NDSR software
Over 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
Time Frame: 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.
Over 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

U.S. Highbush Blueberry Council

Investigators

  • Principal Investigator: Minghua Tang, PhD, University of Colorado Denver | Anschutz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

March 30, 2025

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-1659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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