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

Tracking Information

First Received Date ^ICMJE

January 11, 2007

Last Updated Date

August 27, 2012

Start Date ^ICMJE

January 2006

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00572351 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Red Wine
Intervention: Other: Red Wine
Active Comparator: White Wine
Intervention: Other: White Wine

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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, 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

Gender

Female

Ages

21 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00572351

Other Study ID Numbers ^ICMJE

IRB 6110

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Glenn Braunstein, MD, Cedars Sinai Medical Center

Study Sponsor ^ICMJE

Cedars-Sinai Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Glenn D Braunstein, MD

Cedars Sinai Medical Cneter

Information Provided By

Cedars-Sinai Medical Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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