Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Mayo Clinic San Joaquin Valley Concentrate |
---|---|
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00566553 |
Background The role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of Anti-Estrogens (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents, however, have significant side effects, which are not acceptable to many healthy high-risk women. There is preliminary evidence that GSE acts as natural aromatase inhibitor1.
Commercial preparations of GSE are available as dietary supplements. Methods Plasma levels of estrone, estradiol, estrone-conjugates, testosterone and androstenedione will be measured prior to and 12 weeks after daily ingestion of GSE in 40 healthy postmenopausal women randomly assigned to one of four different doses.
Significance This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors. If we can prove that GSE decreases plasma estrogen levels we will conduct a larger study evaluating the use of GSE as a chemopreventive agent with mammographic breast density used as surrogate marker. The goal of this future study will be detection of a decrease in breast density in women taking GSE leading to large-scale recommendations of GSE to millions of healthy postmenopausal women to reduce their risk of breast cancer in a natural way.
Condition | Intervention | Phase |
---|---|---|
Postmenopausal Women |
Dietary Supplement: Grape-Seed Extract |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study |
Estimated Enrollment: | 40 |
Study Design/Overview This is a dose-finding pilot study. Plasma estrogen (E1, E2, E1-conjugates) and precursor androgen (testosterone and androstenedione) levels will be measured prior to and 12 weeks after daily ingestion of GSE in one of 4 (randomly assigned) doses in healthy postmenopausal women. Assuming a drop out rate of about 50% during the study, we plan to recruit 80 patients from the outpatient Regional Section of the Division of General Internal Medicine to yield a total of 40 subjects on whom the final hormonal measurements will be assayed.
Baseline visit
Patients will receive an appointment at the Charlton GCRC.
Return visit at 12 weeks
Ages Eligible for Study: | 55 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Eligibility Criteria:
Exclusion Criteria
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Dietlind L. Wahner-Roedler, M.D. | Mayo Clinic |
Study ID Numbers: | 06-009628 |
Study First Received: | November 30, 2007 |
Last Updated: | November 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00566553 History of Changes |
Health Authority: | United States: Institutional Review Board |
Estrogens |