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| Name | Class |
|---|---|
| U.S. Highbush Blueberry Council | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants will be provided pre-made whole blueberry freeze-dried powder to be consumed. |
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| Placebo Group | Placebo Comparator | Placebo powder with matching color and texture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry Powder | Other | Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minghua Tang, PhD | University of Colorado Denver | Anschutz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40977976 | Derived | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo Powder | Other | Administered one packet per day (10 grams/packet) and participants consume up to 10 grams per day. |
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