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

November 2, 2012
August 25, 2014
November 2012
July 2015   (final data collection date for primary outcome measure)
Urinary 2:16 ratio [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Urinary 2:16 ratios between treatment groups.
Same as current
Complete list of historical versions of study NCT01726127 on ClinicalTrials.gov Archive Site
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.
Same as current
  • 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.
Same as current
 
Green Vegetables and Women's Health
Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Dietary Modification
  • Other: Broccoli and Brussels Sprouts
  • Dietary Supplement: Cruciferous Complete
  • Other: Placebo
  • Experimental: Broccoli and Brussels Sprouts
    Subjects will consume broccoli or Brussels sprouts (40g daily) for 8 weeks.
    Intervention: Other: Broccoli and Brussels Sprouts
  • Experimental: Cruciferous Complete
    Subjects will take Cruciferous CompleteTM supplements (2 capsules, 3 times daily) for 8 weeks.
    Intervention: Dietary Supplement: Cruciferous Complete
  • Placebo Comparator: Placebo
    Subjects will take placebo capsules (2 capsules, 3 times daily) for 8 weeks.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Female
40 Years to 50 Years
Yes
Contact: Stephanie J Mondloch, BS (608) 262-5820 smondloch@wisc.edu
United States
 
NCT01726127
2011-0872
No
University of Wisconsin, Madison
University of Wisconsin, Madison
Standard Process Inc.
Principal Investigator: Sherry A. Tanumihardjo, PhD University of Wisconsin, Madison
Principal Investigator: Neil Binkley, MD University of Wisconsin, Madison
University of Wisconsin, Madison
August 2014

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