Breast Feeding
Conditions
Keywords
walnut, mediterranean
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.
Interventions
OTHERWalnut
Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
OTHERMyPyramid
Participants will follow a USDA MyPyramid style diet for lactating moms.
Sponsors
California Walnut Commission
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estrogen associated hormones | 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. |
| inflammatory and oxidative stress biomarkers | 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. |
| body measurements | baseline, 2, 4, 6, and 12 months | Assess repeated measures of change in body weight and composition related to dietary group assignment. |
| diet adherence | 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. |
Countries
United States
Outcome results
None listed