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

NCT00566553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-01-06

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Grape Seed Extract

200 mg dose daily for 12 weeks.

DIETARY_SUPPLEMENT

Grape Seed Extract

400 mg dose daily for 12 weeks.

DIETARY_SUPPLEMENT

Grape Seed Extract

600 mg dose daily for 12 weeks.

DIETARY_SUPPLEMENT

Grape Seed Extract

800 mg dose daily for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Dietlind L. Wahner-Roedler, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566553 on ClinicalTrials.gov