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Blueberry Intake and Infant Gut Health

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT05006989
Collaborator
U.S. Highbush Blueberry Council (Other)
152
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Blueberry Powder
  • Other: Placebo Powder
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Basic Science
Official Title:
Blueberry Intake and Infant Gut Health
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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

Other: Blueberry Powder
Administered 10 grams/day
Placebo Comparator: Placebo Group

Participants will be provided placebo powder to be consumed.

Other: Placebo Powder
Administered 10 grams/day

Outcome Measures

Primary Outcome Measures

  1. Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing [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).

  2. Infant Growth (Length) [Over 7 months]

    Measured in cm

  3. Infant Growth (Weight) [Over 7 months]

    Measured in kg

  4. Dietary Intake [Over 7 months]

    3 day dietary recall with results generated by NDSR software

  5. Serum hsCRP (High-Sensitivity C-Reactive Protein) [Over 7 months]

    Measured in mg/L

  6. Serum TNF-α (Tumor Necrosis Factor alpha) [Over 7 months]

    Measured in pg/mL

  7. Serum AGP (Alpha-1-Acid Glycoprotein) [Over 7 months]

    Measured in mg/mL

  8. Serum sCD14 (Soluble CD14) [Over 7 months]

    Measured in µg/mL

  9. Fecal Calprotectin [Over 7 months]

    Measured in µg/g

Secondary Outcome Measures

  1. Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Months to 5 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • U.S. Highbush Blueberry Council

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT05006989
Other Study ID Numbers:
  • 20-1659
First Posted:
Aug 16, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Blueberries
Gut microbiota
Inflammation
Innate immunity
Early complementary feeding

Study Results

No Results Posted as of Sep 16, 2021