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OpenTrials
Completed

NCT Number: NCT00572351

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red Wine

Other

8 ounces of assigned beverage (red wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.

White Wine

Other

8 ounces of assigned beverage (white wine) each evening and abstinence from any other alcoholic beverages, grape juice, grapes, or raisins.

Primary outcomes

  1. blood estrogen and progesterone levels

    Time frame: 15 minutes

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 13, 2007
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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