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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03744429
Enrollment
32
Registered
2018-11-16
Start date
2019-04-16
Completion date
2024-09-30
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Diet on Breast Milk Composition

Keywords

Breast Milk, Mediterranean Diet

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.

Interventions

OTHERMediterranean Diet

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

Sponsors

Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in breast milk fat concentration by mid-infrared spectroscopyThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026