Infant DevelopmentNCT05006989
Blueberry Intake and Infant Gut Health
A study testing Blueberry Powder in people with Infant Development, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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).
Read the 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.
- Conditions
- Infant Development
- Being tested
- Blueberry Powder, Placebo Powder
- Keywords
- Blueberries, Gut microbiota, Inflammation, Innate immunity, Early complementary feeding
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry PowderOther
Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.
Placebo PowderOther
Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will be provided pre-made whole blueberry freeze-dried powder to be consumed. Receives: Other: Blueberry Powder |
| Placebo Group | Placebo comparator | Placebo powder with matching color and texture. Receives: Other: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Over 7 months
Infant Growth (Length)
Measured in cm
Measured: Over 7 months
Infant Growth (Weight)
Measured in kg
Measured: Over 7 months
Dietary Intake
3 day dietary recall with results generated by NDSR software
Measured: Over 7 months
Secondary outcomes (1)
Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
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.
Measured: Over 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Oct 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Sponsor
- Investigators
- Minghua Tang, PhD, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006989
- Sponsor's protocol ID
- 20-1659
- Status last verified
- Apr 2025
- First submitted
- 19 Jul 2021
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40977976
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blueberry Intake and Infant Gut Health
- ClinicalTrials.gov ID
- NCT05006989
- Acronym / sponsor ID
- 20-1659
- Conditions
- Infant Development
- Keywords
- Blueberries, Gut microbiota, Inflammation, Innate immunity, Early complementary feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Blueberry PowderParticipants will be provided pre-made whole blueberry freeze-dried powder to be consumed. |
| Placebo Group | Placebo comparator | Other: Placebo PowderPlacebo powder with matching color and texture. |
Who may qualify
- Ages
- 4 to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry PowderAdministered one packet per day (10 grams/packet) and participants consume up to 10 grams per day. | Other | Intervention Group |
| Placebo PowderAdministered one packet per day (10 grams/packet) and participants consume up to 10 grams per day. | Other | Placebo Group |
Primary outcome
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).
Infant Growth (Length)
Time frame: Over 7 months
Measured in cm
Infant Growth (Weight)
Time frame: Over 7 months
Measured in kg
Dietary Intake
Time frame: Over 7 months
3 day dietary recall with results generated by NDSR software
1 secondary outcome
Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis
Time frame: Over 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 40977976Glime 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minghua Tang, PhD principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Powder in people with Infant Development, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing (time frame: Over 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.