Blueberry Intake and Infant Gut Health

NCT ID: NCT05006989

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-03-30

Brief Summary

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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

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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.

Conditions

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Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Blueberry Powder

Intervention Type OTHER

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

Placebo Group

Placebo powder with matching color and texture.

Group Type PLACEBO_COMPARATOR

Placebo Powder

Intervention Type OTHER

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

Interventions

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Blueberry Powder

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

Intervention Type OTHER

Placebo Powder

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Months

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Highbush Blueberry Council

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minghua Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado Denver | Anschutz

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40977976 (View on PubMed)

Other Identifiers

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20-1659

Identifier Type: -

Identifier Source: org_study_id

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