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NCT01459991 · ClinicalTrials.gov registry record · NA
The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
A NA study, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 138
- Enrollment target
NCT01459991: Completed NA study, sponsored by University of Arizona.
NCT01459991 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 138 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01459991, a NA study, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 138 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Walnut
- OTHER MyPyramid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT01459991 record still lists
NCT01459991 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Walnut is the first listed.
NCT01459991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01459991 about?
NCT01459991 is a clinical study titled "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....
What is the current status of trial NCT01459991?
This trial is currently completed. It is a NA study. The enrollment target is 138 participants. The study started on 2008-10. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01459991?
The interventions under investigation include: Walnut (OTHER), MyPyramid (OTHER).
Who is sponsoring clinical trial NCT01459991?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01459991's enrollment target sits among peer trials
138 720th of 2000 higher than 1,279 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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