Study Results
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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COMPLETED
NA
75 participants
INTERVENTIONAL
2021-09-01
2025-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Intervention Group
Participants will be provided pre-made whole blueberry freeze-dried powder to be consumed.
Blueberry Powder
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.
Placebo Powder
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.
Placebo Powder
Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pre-term
* Consumed formula for more than two weeks
* Not willing to consume the blueberry/placebo powders
4 Months
5 Months
ALL
Yes
Sponsors
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U.S. Highbush Blueberry Council
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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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
Countries
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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.
Other Identifiers
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20-1659
Identifier Type: -
Identifier Source: org_study_id
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