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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 is a NA study that has completed, run by University of Arizona. The registered enrollment target is 138 participants.

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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.

Interventions

  • OTHER Walnut
  • OTHER MyPyramid

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2008-10
Est. Completion 2011-10
Phase NA

Sponsor

University of Arizona

349 total trials

What the Registry Record Tells You About NCT01459991

The ClinicalTrials.gov registry entry for NCT01459991 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Walnut is the first listed.

NCT01459991 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.