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OpenTrials
Completed

NCT Number: NCT05006989

Blueberry Intake and Infant Gut Health

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).

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Key information

Conditions

Infant Development Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

4 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blueberry Powder

Other

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

Placebo Powder

Other

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

Primary outcomes

  1. 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).

  2. Infant Growth (Length)

    Time frame: Over 7 months

    Measured in cm

  3. Infant Growth (Weight)

    Time frame: Over 7 months

    Measured in kg

  4. Dietary Intake

    Time frame: Over 7 months

    3 day dietary recall with results generated by NDSR software

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • U.S. Highbush Blueberry Council

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 16, 2021
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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