The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women
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Purpose
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 | Intervention |
|---|---|
|
Breast Cancer |
Dietary Supplement: Grape Seed Extract |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 39 |
| Study Start Date: | February 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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®
|
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.
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 More Information
Additional Information:
Publications:
| Responsible Party: | Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00566553 History of Changes |
| Other Study ID Numbers: | 06-009628 |
| Study First Received: | November 30, 2007 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Grape Seed Extract Breast Cancer Estrogen Levels Aromatase Inhibitor |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estrogens Aromatase Inhibitors Grape Seed Extract Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antioxidants Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013