The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study
Early detection of breast cancer with screening mammography and the use of more effective
medical therapies have led to a decrease in breast cancer mortality. However, breast cancer
is still the second leading cause of cancer death in women (2). Therefore, the future lies
in not only early detection but prevention of breast cancer. Currently available
chemopreventive agents are associated with potentially serious side effects and can be quite
costly, especially when taken for extended periods of time. Therefore, they are usually
targeted only to women at high risk of disease. Identification of an inexpensive,
efficacious preventive therapy with few or no side effects would represent a major advance
in reducing the morbidity and mortality due to breast cancer. One exciting possibility is
grape seed extract. Grapes and grape seeds contain procyanidins, a highly active subclass of
flavonoids with actions similar to pharmaceutical aromatase inhibitors (AIs). These
procyanidin dimers have been found to suppress estrogen biosynthesis both in vitro and in
animal models (1). Based upon this knowledge we proposed this dose finding pilot study.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To document that grape seed extract taken orally will decrease plasma estrogen levels (estrone (E1), estradiol (E2), and E1-conjugates) and increase precursor androgen levels (testosterone and androstenedione) in healthy postmenopausal women.
12 weeks
No
Dietlind L. Wahner-Roedler, M.D.
Principal Investigator
Mayo Clinic
United States: Institutional Review Board
06-009628
NCT00566553
February 2008
September 2011
Name | Location |
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Mayo Clinic | Rochester, Minnesota 55905 |