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

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.

Study Overview

• Status: Completed
• Conditions: Breast Feeding
• Intervention / Treatment: Other: Walnut; Other: MyPyramid

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85716
      • Nutrition Research Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean; 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.	Other: Walnut; Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
Active Comparator: MyPyramid	Other: MyPyramid; Participants will follow a USDA MyPyramid style diet for lactating moms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estrogen associated hormones	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.	baseline, 2 month, 4 month, 6 month, 12 month
inflammatory and oxidative stress biomarkers	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.	baseline, 2, 4, 6, and 12 months
body measurements	Assess repeated measures of change in body weight and composition related to dietary group assignment.	baseline, 2, 4, 6, and 12 months
diet adherence	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.	Baseline, 2, 4, 6, and 12 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: California Walnut Commission

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Estimate): October 28, 2011
• Last Update Submitted That Met QC Criteria: October 26, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: walnut; mediterranean
• Other Study ID Numbers: Walnut Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No