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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Other: Red Wine
Other: White Wine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • blood estrogen and progesterone levels [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Red Wine Other: 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 Other: White Wine
8 ounces of assigned beverage (white wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572351

Locations
United States, California
Cedars-Sinai Women's Heart Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Glenn D Braunstein, MD Cedars Sinai Medical Cneter
  More Information

No publications provided by Cedars-Sinai Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Glenn Braunstein, MD, Cedars Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00572351     History of Changes
Other Study ID Numbers: IRB 6110
Study First Received: January 11, 2007
Last Updated: August 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Wine

Additional relevant MeSH terms:
Estrogens
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Progestins

ClinicalTrials.gov processed this record on May 19, 2013