Early Life Feeding Exposure and Infant Immune and Health Status.

Part of paid clinical trials in Moscow, Idaho.

Sponsor
University of Idaho
Study ID
NCT05986539
Status
Recruiting
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Conditions

  • Breast Milk Collection
  • Infant Development
  • Maternal Behavior
  • Maternal Obesity

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Observational — OTHER
    This study is only observational in nature and will not include an intervention.

Study Details

Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions.

Key Dates

Start date
Jan 12, 2024
Status verified
Jul 2024
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Breastfeeding dyad
    Women, and their infants, that intend to exclusively breastfeed or begin using formula as supplemental to breastmilk throughout the study.
  • Arm: Formula feeding dyads
    Women, and their infants, that intend to exclusively use formula from 6-18 weeks of life, the duration of the study,

Primary Outcome Measure

Characterize the change in systemic inflammatory profile of healthy full-term infants [ Time Frame: Through study completion, an average of 12 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IdahoMoscowIdaho83844
Bethaney Fehrenkamp, PhD
[email protected]
208-885-1121
[email protected]
Bethaney Fehrenkamp, PhD (PRINCIPAL_INVESTIGATOR)

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University of Idaho· Moscow, ID

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