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

Not Applicable

Completed

• Conditions: Breast Feeding
• Interventions: Other: MyPyramid; Other: Walnut

• Registration Number: NCT01459991
• Lead Sponsor: University of Arizona

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2010-12
• Status Verified: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-26
• Last Update Submitted: 2011-10-26
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyPyramid	MyPyramid	-
Mediterranean	Walnut	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.

Primary Outcome Measures

Name	Time	Method
inflammatory and oxidative stress biomarkers	baseline, 2, 4, 6, and 12 months	Determine indirect/secondary effects of diet intervention on biomarkers of inflammation and oxidative stress as measured by serum high sensitivity C-reactive protein (hsCRP) and urinary 15-iso-prostaglandin-F2alpha (8-iso-PGF2alpha), respectively.
body measurements	baseline, 2, 4, 6, and 12 months	Assess repeated measures of change in body weight and composition related to dietary group assignment.
Estrogen associated hormones	baseline, 2 month, 4 month, 6 month, 12 month	To assess the effect of diet change on estrogen-associated hormones as measured by estradiol-17 beta in serum and breast milk, as well as sex hormon binding globulin (SHBG) in serum among lactating women.
diet adherence	Baseline, 2, 4, 6, and 12 months	Evaluate adherence and exposure to the diet intervention using the objective plasma biomarker, alpha-linolenic acid. Alpha-linolenic acid will be measured in breast milk as well as maternal plasma as a biomarker of intake/exposure.

Trial Locations

Locations (1)

Nutrition Research Clinic; 🇺🇸 Tucson, Arizona, United States