The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
NCT ID: NCT01459991
Last Updated: 2011-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
138 participants
INTERVENTIONAL
2008-10-31
2011-10-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Walnut
Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
MyPyramid
MyPyramid
Participants will follow a USDA MyPyramid style diet for lactating moms.
Interventions
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Walnut
Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
MyPyramid
Participants will follow a USDA MyPyramid style diet for lactating moms.
Eligibility Criteria
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Inclusion Criteria
* no nut allergies
* no history of cancer, renal disease, liver disease, or diabetes
* no smoking
18 Years
40 Years
FEMALE
Yes
Sponsors
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California Walnut Commission
OTHER
University of Arizona
OTHER
Responsible Party
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Locations
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Nutrition Research Clinic
Tucson, Arizona, United States
Countries
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Other Identifiers
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Walnut Study
Identifier Type: -
Identifier Source: org_study_id