Trial record 7 of 25 for:    Open Studies | "Women's Health"

Green Vegetables and Women's Health

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Standard Process Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01726127
First received: November 2, 2012
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

The 2010 Dietary Guidelines for Americans recommend that individuals consume 4.5 to 5 cups fruits and vegetables daily. However, at current intake levels, fruit consumption will have to improve by more than 100% and vegetable intake by 50% to meet this recommendation. Importantly, intake of brightly colored fruits and vegetables is even lower when potatoes are not considered. It is possible that improved fruit and vegetable intake will have beneficial health effects. For example, higher intakes of fruits and vegetables, and particularly cruciferous vegetables (e.g., broccoli, Brussels sprouts, cauliflower, etc.), are associated with lower rates of many degenerative diseases, including some cancers, yet this group of vegetables may continue to be under-consumed due to their strong flavors. A supplement made from these vegetables (Cruciferous CompleteTM made by Standard Process Inc. Palmyra, WI) contains a group of phytochemicals called glucosinolates that can shift estrogen metabolism in a favorable way. One proposed biomarker of chemoprotection from breast cancer is the urinary estrogen metabolite ratio of 2- to 16α-hydroxyestrogens (2:16). In the main study, the effects of cruciferous vegetables (broccoli or Brussels sprouts), Cruciferous CompleteTM whole food supplements, or placebos on this ratio of urinary estrogen metabolites in healthy premenopausal women will be compared over an eight-week period. The investigators hypothesize that treatment with daily supplements will increase the 2:16 ratio as compared to daily consumption of a combination of Brussels sprouts and broccoli or a placebo, suggesting reduced breast cancer risk.

In a sub-study, the relationships between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene with dietary carotenoid intake as measured by a food frequency questionnaire and body composition will be evaluated in healthy premenopausal women. Carotenoids are a family of lipophilic compounds found primarily in colorful plant tissues and their concentration in human blood reflects dietary intake of carotenoid-rich foods. Carotenoid levels in the blood of healthy women do not appear to be influenced by menstrual status, but are inversely associated with body fatness. Thus, serum carotenoid concentrations may serve as a functional marker for chronic disease risk associated with excess body fat.


Condition Intervention
Dietary Modification
Other: Broccoli and Brussels Sprouts
Dietary Supplement: Cruciferous Complete
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Urinary 2:16 ratio [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Urinary 2:16 ratios between treatment groups.


Secondary Outcome Measures:
  • Urinary 4OHE1 and 4OHE2 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.


Other Outcome Measures:
  • Body composition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Association between body composition, urinary 2:16 ratio, and urinary 4OHE metabolites.

  • Stability of urinary 2:16 ratio. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in the urinary 2:16 ratio over 8 weeks in the placebo group.

  • Sub-study: Serum carotenoids and dietary intake [ Time Frame: One blood draw on one day ] [ Designated as safety issue: No ]
    Correlation between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene and dietary intake.

  • Sub-study: Serum carotenoids and body composition [ Time Frame: One blood draw on one day ] [ Designated as safety issue: No ]
    Correlation between serum carotenoids and body composition.

  • Dietary Intake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Association between dietary intake, urinary 2:16 ratio, and urinary 4OHE metabolites.


Estimated Enrollment: 66
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Broccoli and Brussels Sprouts
Subjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks.
Other: Broccoli and Brussels Sprouts
Experimental: Cruciferous Complete
Subjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks.
Dietary Supplement: Cruciferous Complete
Placebo Comparator: Placebo
Subjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks.
Other: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Premenopausal women between the ages of 40-50; premenopause is defined as regular menstrual cycles every 23-35 days
  • Willing to be randomized and compliant to the 3 study groups (whole cruciferous vegetable intake, cruciferous supplement or placebo capsules)
  • Able to give informed consent.

Exclusion Criteria:

  • Urinary 2:16 > or = 3.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726127

Contacts
Contact: Stephanie J Mondloch, BS (608) 262-5820 smondloch@wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Osteoporosis Clinical Research Program Clinic Recruiting
Madison, Wisconsin, United States, 53705
Contact: Stephanie J Mondloch, BS    608-262-5820    smondloch@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Standard Process Inc.
Investigators
Principal Investigator: Sherry A. Tanumihardjo, PhD University of Wisconsin, Madison
Principal Investigator: Neil Binkley, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01726127     History of Changes
Other Study ID Numbers: 2011-0872
Study First Received: November 2, 2012
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014