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Indole-3-Carbinol Effects on Estrogen Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00988845
Recruitment Status : Terminated (Slow accrual in the high BMI group)
First Posted : October 2, 2009
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief Summary:
This study will test a dietary supplement, indole-3-carbinol, for improving the estrogen profile in women across a range of body mass index.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Indole-3-carbinol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Dietary Indole-3-Carbinol on Estrogen Metabolites Across a Wide Range of Body Mass Index: Implications for the Prevention of Endometrial Cancer in Obese Women
Study Start Date : September 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Indole-3-carbinol Dietary Supplement: Indole-3-carbinol
200 mg bid po X 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in urinary 2/16-hydroxyestrone ratio [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • woman aged from 30 - 50 years
  • regular menstrual cycle

Exclusion Criteria:

  • taking hormone replacement or hormonal contraception
  • thyroid disorder
  • uncontrolled asthma
  • BMI under 18.5
  • allergy to cruciferous vegetables
Contacts and Locations
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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): NCT00988845


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Joseph P Connor, MD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00988845    
Other Study ID Numbers: H-2009-0093
CC09709 ( Other Identifier: UW Carbone Cancer Center )
A532800 ( Other Identifier: UW Madison )
SMPH\OBSTET & GYNECOL\OB-GYN ( Other Identifier: UW Madison )
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: April 2015
Keywords provided by University of Wisconsin, Madison:
dietary supplement
indole 3 carbinol
estrogen
Additional relevant MeSH terms:
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Indole-3-carbinol
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents