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

January 4, 2012 updated by: Dietlind Wahner-Roedler, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
400 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
600 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
800 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Active Comparator: Grape Seed Extract # 2
200 mg [2 pills]
Dietary supplement: Grape Seed Extract
200 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
400 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
600 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
800 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Active Comparator: Grape Seed Extract # 3
200 mg [3 pills]
Dietary supplement: Grape Seed Extract
200 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
400 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
600 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
800 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Active Comparator: Grape Seed Extract # 4
200 mg [4 pills]
Dietary supplement: Grape Seed Extract
200 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
400 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
600 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®
Dietary supplement: Grape Seed Extract
800 mg dose daily for 12 weeks.
Other Names:
  • ActiVin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimate)

December 3, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-009628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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