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

NCT00572351 | Completed DMC

• 1 other identifier: IRB 6110
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Wine

Outcome Measures

Primary Outcomes (1)

• blood estrogen and progesterone levels

  15 minutes

Study Arms (2)

Red Wine

ACTIVE COMPARATOR

Other: Red Wine

White Wine

ACTIVE COMPARATOR

Other: White Wine

Interventions

Red Wine OTHER

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

Red Wine

White Wine OTHER

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

White Wine

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• 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.

  PMID: 22150098 DERIVED

Study Officials

• Glenn D Braunstein, MD

  Cedars Sinai Medical Cneter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Barbra Streisand Women's Heart Center at Cedars-Sinai Medical Center

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)