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Indole-3-Carbinol Effects on Estrogen Metabolism

This study has been terminated.
(Slow accrual in the high BMI group)
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00988845
First received: October 1, 2009
Last updated: July 8, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Obesity
 Dietary Supplement: Indole-3-carbinol
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in urinary 2/16-hydroxyestrone ratio [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indole-3-carbinol Dietary Supplement: Indole-3-carbinol
200 mg bid po X 8 weeks

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988845

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Joseph P Connor, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Joseph P. Connor, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00988845     History of Changes
Other Study ID Numbers: H-2009-0093, CC09709
Study First Received: October 1, 2009
Last Updated: July 8, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
dietary supplement
indole 3 carbinol
estrogen

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Estrogens
Indole-3-carbinol
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013