- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00572351
The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels
April 22, 2019 updated by: Noel Bairey Merz, Cedars-Sinai Medical Center
Healthy pre-menopausal women will be recruited in order to test the effects of red wine and white wine on blood estrogen and progesterone levels.
The women will be randomized and rotated through two different treatments (red wine, white wine).
Estrone and estradiol are hormones in the category of estrogens.
It is known that the bodies of both men and women may convert (or aromatize) a certain amount of naturally occurring testosterone into estrogen.
Aromatase inhibitors have been used to prevent this conversion, or aromatization, of testosterone into estrogen, in the treatment of estrogen-dependent breast cancer in women.
This inhibition leads to a marked decrease in estrogen (estradiol and estrone) levels.
Naturally occurring aromatase inhibitors include grapes, grape juice, and red, but not white wine.
The aromatase inhibitory effects are attributed to wine phytochemicals and not to alcohol.
Based upon this information, the investigators will monitor the estrogen levels at various phases in the menstrual cycles of women since hormone levels naturally vary throughout the menstrual cycle.
Several epidemiologic studies have found that there is a correlation with moderate to high levels of alcohol consumption and breast cancer.
Therefore, study participants will be asked to drink only a eight ounces of wine which should have minimal or no risk for the development of breast cancer.
Study Overview
Study Type
Interventional
Enrollment (Actual)
44
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
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Women's Heart Center
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female
- pre-menopausal with regular ovulatory cycles for 12 months prior to the study
- willingness and ability to participate in study requiring alcohol consumption
- in general good health
- BMI of 18.5-35
- on regular, unrestricted diet
- not currently, or within the past 3 months, using oral contraceptives or other hormone replacement therapy
Exclusion Criteria:
- male
- irregular menstrual cycles or vasomotor symptoms within the last 12 months
- pregnant (or breast feeding)
- any hormone therapy including phytoestrogens, oral contraceptives, SERMs (selective estrogen receptor modulators), or androgens (or precursors) for three months prior to the study
- history of alcohol abuse
- history of any estrogen-dependent neoplasia
- high intake of dietary soy products
- Minors < age 21 years
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Red Wine
|
8 ounces of assigned beverage (red wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.
|
Active Comparator: White Wine
|
8 ounces of assigned beverage (white wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood estrogen and progesterone levels
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Glenn D Braunstein, MD, Cedars Sinai Medical Cneter
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.
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
January 1, 2006
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
January 11, 2007
First Submitted That Met QC Criteria
December 12, 2007
First Posted (Estimate)
December 13, 2007
Study Record Updates
Last Update Posted (Actual)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 22, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB 6110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
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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