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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Feeding

Intervention / Treatment
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* Other: Walnut
* Other: MyPyramid


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean<br>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<br>* Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.<br>|
| Active Comparator: MyPyramid<br> | Other: MyPyramid<br>* Participants will follow a USDA MyPyramid style diet for lactating moms.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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walnut, mediterranean