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

Effect of Diet on Breast Milk Composition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03744429
• Other study ID #: 228407
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: February 2024

Study information

• Verified date: July 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Effect of Diet on Breast Milk Composition

Intervention

Other:
• Mediterranean Diet
Participants will be provided with meals that follow a Mediterranean meal plan.

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in breast milk fat concentration by mid-infrared spectroscopy	The primary aim is to test whether the dietary intervention modifies the breast milk fat concentration of obese mothers.	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.