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

NCT ID: NCT03744429

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Effect of Diet on Breast Milk Composition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mediterranean Diet

Intervention Type OTHER

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

Interventions

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Mediterranean Diet

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chelsey Fiecke, PhD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Nutrition Center

Locations

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Arkansas Children's Nutrition Center

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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228407

Identifier Type: -

Identifier Source: org_study_id

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