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Completed

NCT Number: NCT01459991

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

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.

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Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Research Clinic

Tucson, Arizona, 85716, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walnut

Other

Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.

MyPyramid

Other

Participants will follow a USDA MyPyramid style diet for lactating moms.

Primary outcomes

  1. Estrogen associated hormones

    Time frame: baseline, 2 month, 4 month, 6 month, 12 month

    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.

  2. inflammatory and oxidative stress biomarkers

    Time frame: baseline, 2, 4, 6, and 12 months

    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.

  3. body measurements

    Time frame: baseline, 2, 4, 6, and 12 months

    Assess repeated measures of change in body weight and composition related to dietary group assignment.

  4. diet adherence

    Time frame: Baseline, 2, 4, 6, and 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • California Walnut Commission

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Oct 26, 2011
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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