Clinical trial NCT00572351: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Wine
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2007-12-13
Enrollment: 44
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: blood estrogen and progesterone levels
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Women's Heart Center
state: California
Study officials:
affiliation: Cedars Sinai Medical Cneter
name: Glenn D Braunstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.