Early Life Feeding Exposure and Infant Immune and Health Status.

NCT05986539 | Recruiting

• 1 other identifier: 23-013
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Characterize the change in systemic inflammatory profile of healthy full-term infants

  We will investigate infant inflammation across the first 4.5 months of life in serum and feces using biomarkers C-reactive protein, tumor necrosis factor-alpha, and other inflammatory interleukins and cytokines.

  Through study completion, an average of 12 weeks.

Secondary Outcomes (1)

• Characterize the potential correlation between maternal systemic inflammation and inflammatory profile of the breastmilk.

  Through study completion, an average of 12 weeks.

Other Outcomes (1)

• Characterize the change in blood mononuclear cell distribution of healthy full term infants.

  Through study completion, an average of 12 weeks.

Study Arms (2)

Breastfeeding dyad

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

Other: Observational

Formula feeding dyads

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

Other: Observational

Interventions

Observational OTHER

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

Also known as: Observation only based on natural experiment of feeding groups

Breastfeeding dyad; Formula feeding dyads

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This project is focused on the effects of maternal inflammation and health status on the developing infant, including the role of breastfeeding and early feeding practices.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population is postnatal women and their infant dyads.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Idaho: lead

Study Sites (1)

University of Idaho

Moscow, Idaho, 83844, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Breastmilk samples will be collected when a woman is breastfeeding. Infant fecal samples will be collected. Maternal and infant blood samples will be collected. Women can optionally submit saliva and fecal samples.

MeSH Terms

Conditions

Pregnancy in Obesity; Breast Milk Expression

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Breast Feeding; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Bethaney Fehrenkamp, PhD

  University of Idaho Clinical Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethaney Fehrenkamp, PhD

CONTACT

208-885-1121; bethaney@uidaho.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: August 14, 2023
• Study Start: January 12, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)