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Clinical Trials/NCT03744429
NCT03744429
Completed
Not Applicable

A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women

Arkansas Children's Hospital Research Institute1 site in 1 country32 target enrollmentApril 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Effect of Diet on Breast Milk Composition
Sponsor
Arkansas Children's Hospital Research Institute
Enrollment
32
Locations
1
Primary Endpoint
Change in breast milk fat concentration by mid-infrared spectroscopy
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.

Registry
clinicaltrials.gov
Start Date
April 16, 2019
End Date
September 30, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • ≤4.5 months postpartum
  • BMI 30 - 50 kg/m2
  • ≥ 18 years of age
  • Singleton pregnancy
  • Exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum
  • Mother has a breast pump
  • Mother is willing to collect breast milk for a 24 hour period.

Exclusion Criteria

  • Pre-existing conditions (e.g. diabetes, hypertension, heart disease)
  • Use of recreational drugs, tobacco, or alcohol
  • Use of medications or supplements for which breastfeeding is contraindicated
  • Child has internal metal which may be an NMR safety concern

Outcomes

Primary Outcomes

Change in breast milk fat concentration by mid-infrared spectroscopy

Time Frame: The change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention.

The primary aim is to test whether the dietary intervention modifies the breast milk fat concentration of obese mothers.

Study Sites (1)

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