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

NCT03744429 | Completed DMC

• 1 other identifier: 228407
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Diet on Breast Milk Composition

Keywords

Breast Milk; Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Mediterranean Meal Plan

EXPERIMENTAL

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.

Other: Mediterranean Diet

Interventions

Mediterranean Diet OTHER

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

Mediterranean Meal Plan

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must be breastfeeding.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Interventions

Diet, Mediterranean

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Chelsey Fiecke, PhD

  Arkansas Children's Nutrition Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 16, 2018
• Study Start: April 16, 2019
• Primary Completion: March 13, 2024
• Study Completion: September 30, 2024
• Last Updated: September 30, 2025

Record last verified: 2024-10

Locations

US (1)