NCT01459991

The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Purpose: During lactation, several physiological modifications occur including cellular differentiation and proliferation, as well as elevation in inflammation. The role of the Mediterranean (MED) diet rich in walnuts has been shown to favorably modify fatty acid profiles and to reduce inflammation. The study goal is to evaluate the anti-inflammatory effects of the MED diet rich in walnuts during lactation, a time of increased inflammatory response. Procedures: A randomized, controlled dietary intervention trial among lactating women comparing the effects of a Mediterranean-style diet with walnuts to the USDA's MyPyramid Diet for Moms was commenced to determine the effects of the diet on fatty acid profiles and biomarkers of inflammation in breast milk and material serum/plasma. Secondary outcomes of interest include effects of maternal diet assignment on maternal body weight and body composition as well as infants' growth and health during the study trial period. Population: The study population includes healthy women between the ages of 18-40 years who are within 6 months post-partum and plan to breastfeed a minimum of 3 times per day for 6 months following study entry. There have been a total of 138 participants enrolled in the study. All 138 participants are women; 34 identified themselves as Hispanic, and 104 said they were not Hispanic.

Conditions

• Breast Feeding

Interventions

Type	Name	Description
OTHER	Walnut	Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
OTHER	MyPyramid	Participants will follow a USDA MyPyramid style diet for lactating moms.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-12-01
• Completion: 2011-10-01
• First posted: 2011-10-26
• Last updated: 2011-10-28

Locations

1 site across 1 country: United States