Blueberry Intake and Infant Gut Health

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Blueberry Intake and Infant Gut Health

Conditions
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Infant Development

Intervention / Treatment
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* Other: Blueberry Powder
* Other: Placebo Powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants will be provided pre-made whole blueberry freeze-dried powder to be consumed. | Other: Blueberry Powder<br>* Administered 10 grams/day<br>|
| Placebo Comparator: Placebo Group<br>Participants will be provided placebo powder to be consumed. | Other: Placebo Powder<br>* Administered 10 grams/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Serum hsCRP (High-Sensitivity C-Reactive Protein) | Measured in mg/L | Over 7 months | 
| Serum TNF-α (Tumor Necrosis Factor alpha) | Measured in pg/mL | Over 7 months | 
| Serum AGP (Alpha-1-Acid Glycoprotein) | Measured in mg/mL | Over 7 months | 
| Serum sCD14 (Soluble CD14) | Measured in µg/mL | Over 7 months | 
| Fecal Calprotectin | Measured in µg/g | Over 7 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blueberries, Gut microbiota, Inflammation, Innate immunity, Early complementary feeding