Completed

NCT Number: NCT03744429

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

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.

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Key information

Conditions

Effect of Diet on Breast Milk Composition

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mediterranean Diet

Other

Participants will be provided with meals that follow a Mediterranean meal plan.

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.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute