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

NCT01459991 — Not applicable, Completed, 138 participants, University of Arizona

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Registry	NCT01459991
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	138 (Actual)
Sponsor	University of Arizona (Other); collaborators: California Walnut Commission
Conditions	Breast Feeding
Interventions	Walnut, MyPyramid (Other)
Dates	start 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 in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Mediterranean	Experimental	Other: 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.
MyPyramid	Active comparator	Other: MyPyramid

Walnut (Other): Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
MyPyramid (Other): Participants will follow a USDA MyPyramid style diet for lactating moms.

+Outcome measures

Primary outcomes

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.
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.
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.

+Eligibility

Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers

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:

+Locations (1)

Facility	City	Country	Status
Nutrition Research Clinic	Tucson, Arizona	United States