The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels
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| ClinicalTrials.gov Identifier: NCT00572351 |
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Recruitment Status :
Completed
First Posted : December 13, 2007
Last Update Posted : April 23, 2019
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Sponsor:
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Other: Red Wine Other: White Wine | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Effects of Red Wine and White Wine on Blood Estrogen and Progesterone Levels |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | March 2007 |
| Actual Study Completion Date : | March 2007 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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. |
Primary Outcome Measures :
- blood estrogen and progesterone levels [ Time Frame: 15 minutes ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Noel Bairey Merz, Director of the Barbra Streisand Women's Heart Center at Cedars-Sinai Medical Center, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00572351 History of Changes |
| Other Study ID Numbers: |
IRB 6110 |
| First Posted: | December 13, 2007 Key Record Dates |
| Last Update Posted: | April 23, 2019 |
| Last Verified: | April 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
Keywords provided by Noel Bairey Merz, Cedars-Sinai Medical Center:
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Wine |
Additional relevant MeSH terms:
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Progesterone Estrogens Progestins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |