A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women
Not Applicable
Completed
- Conditions
- Effect of Diet on Breast Milk Composition
- Registration Number
- NCT03744429
- Lead Sponsor
- Arkansas Children's Hospital Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in breast milk fat concentration by mid-infrared spectroscopy 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Arkansas Children's Nutrition Center
🇺🇸Little Rock, Arkansas, United States
Arkansas Children's Nutrition Center🇺🇸Little Rock, Arkansas, United States