Green Vegetables and Women's Health

• ClinicalTrials.gov Identifier: NCT01726127
• Recruitment Status: Completed
• First Posted: November 14, 2012
• Last Update Posted: October 7, 2015
• Sponsor: University of Wisconsin, Madison
• Collaborator: Standard Process Inc.
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Dietary Modification	Other: Broccoli and Brussels Sprouts; Dietary Supplement: Cruciferous Complete; Other: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women
• Study Start Date: November 2012
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Urinary 2:16 ratio [ Time Frame: 8 weeks ]
   Urinary 2:16 ratios between treatment groups.

Secondary Outcome Measures :

1. Urinary 4OHE1 and 4OHE2 [ Time Frame: 8 weeks ]
   Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.

Other Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 50 Years (Adult)
• Sexes 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

Locations

United States, Wisconsin

University of Wisconsin Osteoporosis Clinical Research Program Clinic

Madison, Wisconsin, United States, 53705

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

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT01726127
• Other Study ID Numbers: 2011-0872
• First Posted: November 14, 2012
• Last Update Posted: October 7, 2015
• Last Verified: October 2015