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

This study has been completed.
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00572351
First received: January 11, 2007
Last updated: August 27, 2012
Last verified: August 2012

January 11, 2007
August 27, 2012
January 2006
March 2007   (final data collection date for primary outcome measure)
blood estrogen and progesterone levels [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572351 on ClinicalTrials.gov Archive Site
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The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels
The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
  • 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.
  • Active Comparator: Red Wine
    Intervention: Other: Red Wine
  • Active Comparator: White Wine
    Intervention: Other: White Wine
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.
 
Completed
44
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. female
  2. pre-menopausal with regular ovulatory cycles for 12 months prior to the study
  3. willingness and ability to participate in study requiring alcohol consumption
  4. in general good health
  5. BMI of 18.5-35
  6. on regular, unrestricted diet
  7. not currently, or within the past 3 months, using oral contraceptives or other hormone replacement therapy

Exclusion Criteria:

  1. male
  2. irregular menstrual cycles or vasomotor symptoms within the last 12 months
  3. pregnant (or breast feeding)
  4. any hormone therapy including phytoestrogens, oral contraceptives, SERMs, or androgens (or precursors) for three months prior to the study
  5. history of alcohol abuse
  6. history of any estrogen-dependent neoplasia
  7. high intake of dietary soy products
  8. Minors < age 21 years
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00572351
IRB 6110
Yes
Glenn Braunstein, MD, Cedars Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Glenn D Braunstein, MD Cedars Sinai Medical Cneter
Cedars-Sinai Medical Center
August 2012

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