The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels

Tracking Information
First Submitted Date ICMJE	January 11, 2007
First Posted Date ICMJE	December 13, 2007
Last Update Posted Date	June 5, 2018
Study Start Date ICMJE	January 2006
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 12, 2007)	blood estrogen and progesterone levels [ Time Frame: 15 minutes ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00572351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels
Official Title ICMJE	The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Healthy
Intervention ICMJE	Other: Red Wine 8 ounces of assigned beverage (red wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.; Other: White Wine 8 ounces of assigned beverage (white wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.
Study Arms	Active Comparator: Red Wine Intervention: Other: Red Wine; Active Comparator: White Wine Intervention: Other: White Wine
Publications *	Shufelt C, Merz CN, Yang Y, Kirschner J, Polk D, Stanczyk F, Paul-Labrador M, Braunstein GD. Red versus white wine as a nutritional aromatase inhibitor in premenopausal women: a pilot study. J Womens Health (Larchmt). 2012 Mar;21(3):281-4. doi: 10.1089/jwh.2011.3001. Epub 2011 Dec 7.
* 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: December 12, 2007)	44
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2007
Actual Primary Completion Date	March 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	21 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	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	NCT00572351
Other Study ID Numbers ICMJE	IRB 6110
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes
Responsible Party	Noel Bairey Merz, Cedars-Sinai Medical Center
Study Sponsor ICMJE	Cedars-Sinai Medical Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Glenn D Braunstein, MD Cedars Sinai Medical Cneter
PRS Account	Cedars-Sinai Medical Center
Verification Date	June 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP