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

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

Tracking Information

• First Submitted Date: January 11, 2007
• First Posted Date: December 13, 2007
• Last Update Posted Date: April 23, 2019
• Study Start Date: January 2006
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 12, 2007): blood estrogen and progesterone levels [ Time Frame: 15 minutes ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Healthy

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 12, 2007): 44
• Original Estimated Enrollment: 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

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

• Sexes Eligible for Study: Female

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00572351
• Other Study ID Numbers: IRB 6110
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Cedars-Sinai Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Glenn D Braunstein, MD; Cedars Sinai Medical Cneter

• PRS Account: Cedars-Sinai Medical Center
• Verification Date: April 2019