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

Not Applicable

Completed

• Conditions: Effect of Diet on Breast Milk Composition
• Interventions: Other: Mediterranean Diet

• Registration Number: NCT03744429
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Study Start: 2019-04-16
• Primary Completion: 2024-03-13
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mediterranean Meal Plan	Mediterranean Diet	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.

Primary Outcome Measures

Name	Time	Method
Change in breast milk fat concentration by mid-infrared spectroscopy	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.

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States