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

This study has been completed.
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01459991
First received: October 24, 2011
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Breast Feeding
Other: Walnut
Other: MyPyramid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Estrogen associated hormones [ Time Frame: baseline, 2 month, 4 month, 6 month, 12 month ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 2, 4, 6, and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 2, 4, 6, and 12 months ] [ Designated as safety issue: No ]
    Assess repeated measures of change in body weight and composition related to dietary group assignment.

  • diet adherence [ Time Frame: Baseline, 2, 4, 6, and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 138
Study Start Date: October 2008
Study Completion Date: October 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Walnut
Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
Active Comparator: MyPyramid Other: MyPyramid
Participants will follow a USDA MyPyramid style diet for lactating moms.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459991

Locations
United States, Arizona
Nutrition Research Clinic
Tucson, Arizona, United States, 85716
Sponsors and Collaborators
University of Arizona
California Walnut Commission
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01459991     History of Changes
Other Study ID Numbers: Walnut Study
Study First Received: October 24, 2011
Last Updated: October 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
walnut
mediterranean

ClinicalTrials.gov processed this record on August 21, 2014