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OpenTrials
Completed

NCT Number: NCT01726127

Green Vegetables and Women's Health

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.

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Key information

Age range

40 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Osteoporosis Clinical Research Program Clinic

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Broccoli and Brussels Sprouts

Other

Cruciferous Complete

Dietary Supplement

Placebo

Other

Primary outcomes

  1. Urinary 2:16 ratio

    Time frame: 8 weeks

    Urinary 2:16 ratios between treatment groups.

Secondary outcomes

  1. Urinary 4OHE1 and 4OHE2

    Time frame: 8 weeks

    Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.

Other outcomes

  1. Body composition

    Time frame: 8 weeks

    Association between body composition, urinary 2:16 ratio, and urinary 4OHE metabolites.

  2. Stability of urinary 2:16 ratio.

    Time frame: 8 weeks

    Change in the urinary 2:16 ratio over 8 weeks in the placebo group.

  3. Sub-study: Serum carotenoids and dietary intake

    Time frame: One blood draw on one day

    Correlation between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene and dietary intake.

  4. Sub-study: Serum carotenoids and body composition

    Time frame: One blood draw on one day

    Correlation between serum carotenoids and body composition.

  5. Dietary Intake

    Time frame: 8 weeks

    Association between dietary intake, urinary 2:16 ratio, and urinary 4OHE metabolites.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Standard Process Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2012
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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