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Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Perimenopausal Women


N/A
45 Years
55 Years
Not Enrolling
Female
Dietary Modification

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Trial Information

Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Perimenopausal Women


Inclusion Criteria:



- Perimenopausal women between the ages of 45-55; perimenopause is defined as absence
of a menstrual period for 6-18 months.

- Willing to be randomized and compliant to the 3 study groups (whole cruciferous
vegetable intake, cruciferous supplement or placebo tablets)

- Able to give informed consent.

Exclusion Criteria:

- Urinary 2:16 > or = 2.

- Current kidney or liver disease, adrenalectomy, or oophorectomy.

- Use of tobacco products within the preceding three months, illegal use of medications
or use of illegal drugs or substances.

- Current use of antibiotics, cimetidine or black cohosh.

- Systemic administration of estrogen, or use of non-prescription hormones, tamoxifen,
or diabetes medication within the last three months.

- Women under a physician-directed diet or those with a strong dislike of Brassica
vegetables.

- Presence of cancer in the last 5 years, with the exception of fully resected basal or
squamous cell tumors.

- Participation in an investigational drug study in the last 30 days.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening

Outcome Measure:

Urinary 2:16 ratio

Outcome Description:

Urinary 2:16 ratios between treatment groups.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Sherry A. Tanumihardjo, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2011-0872

NCT ID:

NCT01726127

Start Date:

November 2012

Completion Date:

November 2013

Related Keywords:

  • Dietary Modification
  • Food Habits

Name

Location

University of Wisconsin Osteoporosis Clinical Research Program ClinicMadison, Wisconsin  53705