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

University of Arizona

Status: Completed

Conditions: Breast Feeding

Treatments: Other: MyPyramid; Other: Walnut

Study type: Interventional

Funder types: Other

Identifiers

NCT01459991

Walnut Study

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• plan to breastfeed 3 times daily for 6 months
• no nut allergies
• no history of cancer, renal disease, liver disease, or diabetes
• no smoking

Exclusion Criteria:

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Mediterranean

Experimental group

Description:

Participants in this arm will follow a Mediterranean style diet, rich in olive oil and fruits and vegetables, and also consume 1 ounce of walnuts daily.

Treatment:

Other: Walnut

MyPyramid

Active Comparator group

Treatment:

Other: MyPyramid