The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedOctober 28, 2011
October 1, 2011
2.2 years
October 24, 2011
October 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Mediterranean
EXPERIMENTALParticipants 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 COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- plan to breastfeed 3 times daily for 6 months
- no nut allergies
- no history of cancer, renal disease, liver disease, or diabetes
- no smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- California Walnut Commissioncollaborator
Study Sites (1)
Nutrition Research Clinic
Tucson, Arizona, 85716, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 26, 2011
Study Start
October 1, 2008
Primary Completion
December 1, 2010
Study Completion
October 1, 2011
Last Updated
October 28, 2011
Record last verified: 2011-10