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

Arkansas Children's Hospital Research Institute

Status: Completed

Conditions: Effect of Diet on Breast Milk Composition

Treatments: Other: Mediterranean Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03744429

228407

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Mediterranean Meal Plan

Experimental group

Description:

This is a single arm study in which participants will receive meals that follow a Mediterranean diet plan for 4 weeks. Breast milk samples will be collected before, during, and after the intervention period.

Treatment:

Other: Mediterranean Diet