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

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ClinicalTrials.gov Identifier: NCT00572351
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE January 11, 2007
First Posted Date  ICMJE December 13, 2007
Last Update Posted Date April 23, 2019
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
Current Secondary Outcome Measures  ICMJE Not Provided
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 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  ICMJE 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  ICMJE
  • 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  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (selective estrogen receptor modulators), 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (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 NCT00572351
Other Study ID Numbers  ICMJE IRB 6110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Noel Bairey Merz, Cedars-Sinai Medical Center
Original Responsible Party Glenn Braunstein, MD, Cedars Sinai Medical Center
Current Study Sponsor  ICMJE Cedars-Sinai Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Glenn D Braunstein, MD Cedars Sinai Medical Cneter
PRS Account Cedars-Sinai Medical Center
Verification Date April 2019

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