Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00566553
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : January 6, 2012
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE November 30, 2007
First Posted Date  ICMJE December 3, 2007
Last Update Posted Date January 6, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
Measurements of Plasma Estrogen Levels
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women
Official Title  ICMJE The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Dietary Supplement: Grape Seed Extract
    200 mg dose daily for 12 weeks.
    Other Name: ActiVin®
  • Dietary Supplement: Grape Seed Extract
    400 mg dose daily for 12 weeks.
    Other Name: ActiVin®
  • Dietary Supplement: Grape Seed Extract
    600 mg dose daily for 12 weeks.
    Other Name: ActiVin®
  • Dietary Supplement: Grape Seed Extract
    800 mg dose daily for 12 weeks.
    Other Name: ActiVin®
Study Arms  ICMJE
  • Active Comparator: Grape Seed Extract # 1
    200 mg [1 pill]
    Intervention: Dietary Supplement: Grape Seed Extract
  • Active Comparator: Grape Seed Extract # 2
    200 mg [2 pills]
    Intervention: Dietary Supplement: Grape Seed Extract
  • Active Comparator: Grape Seed Extract # 3
    200 mg [3 pills]
    Intervention: Dietary Supplement: Grape Seed Extract
  • Active Comparator: Grape Seed Extract # 4
    200 mg [4 pills]
    Intervention: Dietary Supplement: Grape Seed Extract
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2011)
39
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2007)
40
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00566553
Other Study ID Numbers  ICMJE 06-009628
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dietlind Wahner-Roedler, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dietlind L. Wahner-Roedler, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP