Recruiting

Observational Study

Sponsor:

University of Idaho

Code:

NCT05986539

Conditions

Maternal Behavior

Maternal Obesity

Breast Milk Collection

Infant Development

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational

Study Details

Brief summary:

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.

Conditions

Maternal Behavior

Maternal Obesity

Breast Milk Collection

Infant Development

Study ID

NCT05986539

Start date

Jan 12, 2024

Status verified date

Jul, 2024

Completion date

Apr 30, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Mother at least 18 years of age
  • Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of age or younger
  • Mother plans to continue to provide your infant breastmilk (by breastfeeding or by pumping) for at least 18 weeks (4.5 months) from your delivery date or mother plans to continue to provide formula exclusively to infant for at least 18 weeks of life.
  • Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples for visits 2, 4, and 6.
  • Mother willing to meet at (designated sample collection site) for visits 3 and 5 for sample collection and visit activities.
  • Mother willing to consent and comply with all aspects of the study protocol and methods, save the optional activities and optional sample collections.
  • Mother and infant are considered healthy by Principle Investigator.
  • For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using maternal BMI and infant sex.

Exclusion Criteria:

  • Mother or Infant have participated or are currently participating in an interventional drug or device (non-observational) research study before.
  • Mother reports that they, or the infant, have had an adverse effect during a venous blood collection.
  • Infant was born less than 36 weeks of gestation.
  • Infant or mother have health conditions that increase the risk of study procedures.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Breastfeeding dyad

Women, and their infants, that intend to exclusively breastfeed or begin using formula as supplemental to breastmilk throughout the study.

Formula feeding dyads

Women, and their infants, that intend to exclusively use formula from 6-18 weeks of life, the duration of the study,

Interventions

Observational

This study is only observational in nature and will not include an intervention.

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 and Locations

Central contacts

Bethaney Fehrenkamp, PhD

208-885-1121bethaney@uidaho.edu

Locations

University of Idaho

Recruiting

Moscow, Idaho, United States, 83844

Contacts

Bethaney Fehrenkamp, PhD

208-885-1121bethaney@uidaho.edu

bethaney@uidaho.edu

Principal Investigator:

Bethaney Fehrenkamp, PhD

More Information

Sponsor

University of Idaho

Last update posted

Jul 26, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Idaho on 2024-07-26.