Blueberry Intake and Infant Gut Health

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Infant Development

Treatments: Other: Placebo Powder; Other: Blueberry Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT05006989

20-1659

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 4 to 5 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

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

Treatment:

Other: Blueberry Powder

Placebo Group

Placebo Comparator group

Description:

Placebo powder with matching color and texture.

Treatment:

Other: Placebo Powder