CompletedNot Applicable

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

United States32 participantsStarted 2019-04-16

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in breast milk fat concentration by mid-infrared spectroscopy

Timeframe: 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.

Trial details

NCT IDNCT03744429

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-13

View on ClinicalTrials.gov More Effect of Diet on Breast Milk Composition trials