The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women

Breast Cancer Clinical Trial

Official title:

The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566553
• Other study ID #: 06-009628
• Status: Completed
• Phase: N/A
• First received: November 30, 2007
• Last updated: January 4, 2012
• Start date: February 2008
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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 grape seed extract acts as "natural" aromatase inhibitor (1). This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 55 - 75 years

• Able to understand and sign a consent form

• Postmenopausal (no menstrual period for 1 year or more)

• No personal cancer history (except for non-melanoma skin cancer)

• No hormone replacement therapy or anti-estrogens within 6 months of baseline

Exclusion Criteria:

• Known allergy to grapes or grape products

• Currently on ACE inhibitors, methotrexate, allopurinol, coumadin (Warfarin, Jantoven), heparin, clopidogrel (Plavix), or cholesterol lowering medication

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Dietary Supplement:
• Grape Seed Extract
200 mg dose daily for 12 weeks.
• Grape Seed Extract
400 mg dose daily for 12 weeks.
• Grape Seed Extract
600 mg dose daily for 12 weeks.
• Grape Seed Extract
800 mg dose daily for 12 weeks.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

American Cancer Society. Cancer Facts and Figures 2005. Atlanta, GA: American Cancer Society; 2005.

Eng ET, Ye J, Williams D, Phung S, Moore RE, Young MK, Gruntmanis U, Braunstein G, Chen S. Suppression of estrogen biosynthesis by procyanidin dimers in red wine and grape seeds. Cancer Res. 2003 Dec 1;63(23):8516-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To determine the most effective, well tolerated dose of grape seed extract resulting in a decrease in plasma estrogen levels (E1, E2, E1-conjugates) and increase in precursor androgens (testosterone and androstenedione).		12 weeks	Yes

External Links

•   American Cancer Society. Cancer Facts & Figures 2005.