Green Vegetables and Women's Health

Dietary Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726127
• Other study ID #: 2011-0872
• Status: Completed
• Phase: N/A
• First received: November 2, 2012
• Last updated: October 5, 2015
• Start date: November 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Other:
• Broccoli and Brussels Sprouts

Dietary Supplement:
• Cruciferous Complete

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of Wisconsin Osteoporosis Clinical Research Program Clinic	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Standard Process Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition	Association between body composition, urinary 2:16 ratio, and urinary 4OHE metabolites.	8 weeks	No
Other	Stability of urinary 2:16 ratio.	Change in the urinary 2:16 ratio over 8 weeks in the placebo group.	8 weeks	No
Other	Sub-study: Serum carotenoids and dietary intake	Correlation between serum a-carotene, ß-carotene, ß-cryptoxanthin, lutein and lycopene and dietary intake.	One blood draw on one day	No
Other	Sub-study: Serum carotenoids and body composition	Correlation between serum carotenoids and body composition.	One blood draw on one day	No
Other	Dietary Intake	Association between dietary intake, urinary 2:16 ratio, and urinary 4OHE metabolites.	8 weeks	No
Primary	Urinary 2:16 ratio	Urinary 2:16 ratios between treatment groups.	8 weeks	No
Secondary	Urinary 4OHE1 and 4OHE2	Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.	8 weeks	No