A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change in breast milk fat concentration by mid-infrared spectroscopy
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Secondary Outcomes
No secondary outcomes reported