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

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459991
• Other study ID #: Walnut Study
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: October 26, 2011
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Nutrition Research Clinic	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	California Walnut Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	body measurements	Assess repeated measures of change in body weight and composition related to dietary group assignment.	baseline, 2, 4, 6, and 12 months	No
Primary	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	No