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

July 18, 2023 updated by: Arkansas Children's Hospital Research Institute
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterranean Meal Plan
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
Participants will be provided with meals that follow a Mediterranean meal plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Investigators

  • Principal Investigator: Clark Sims, PhD, Arkansas Children's Nutrition Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 16, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 228407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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