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

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University of Arizona

Status

Completed

Conditions

Breast Feeding

Treatments

Other: MyPyramid
Other: Walnut

Study type

Interventional

Funder types

Other

Identifiers

NCT01459991
Walnut Study

Details and patient eligibility

About

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.

Enrollment

138 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

138 participants in 2 patient groups

Mediterranean
Experimental group
Description:
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.
Treatment:
Other: Walnut
MyPyramid
Active Comparator group
Treatment:
Other: MyPyramid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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