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

• ClinicalTrials.gov Identifier: NCT00566553
• Recruitment Status: Completed
• First Posted: December 3, 2007
• Last Update Posted: January 6, 2012
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Dietlind Wahner-Roedler, Mayo Clinic

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Dietary Supplement: Grape Seed Extract	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study
• Study Start Date: February 2008
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Grape Seed Extract # 1; 200 mg [1 pill]	Dietary Supplement: Grape Seed Extract; 200 mg dose daily for 12 weeks.; Other Name: ActiVin®
Active Comparator: Grape Seed Extract # 2; 200 mg [2 pills]	Dietary Supplement: Grape Seed Extract; 400 mg dose daily for 12 weeks.; Other Name: ActiVin®
Active Comparator: Grape Seed Extract # 3; 200 mg [3 pills]	Dietary Supplement: Grape Seed Extract; 600 mg dose daily for 12 weeks.; Other Name: ActiVin®
Active Comparator: Grape Seed Extract # 4; 200 mg [4 pills]	Dietary Supplement: Grape Seed Extract; 800 mg dose daily for 12 weeks.; Other Name: ActiVin®

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. 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). [ Time Frame: 12 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Dietlind L. Wahner-Roedler, M.D.; Mayo Clinic

More Information

Additional Information:

American Cancer Society. Cancer Facts & Figures 2005. 

Publications:

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.

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

• Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00566553
• Other Study ID Numbers: 06-009628
• First Posted: December 3, 2007
• Last Update Posted: January 6, 2012
• Last Verified: January 2012

Keywords provided by Dietlind Wahner-Roedler, Mayo Clinic:

Grape Seed Extract; Breast Cancer; Estrogen Levels; Aromatase Inhibitor

Additional relevant MeSH terms:

Grape Seed Extract; Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs