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Green Vegetables and Women's Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01726127
Enrollment
66
Registered
2012-11-14
Start date
2012-11-30
Completion date
2015-09-30
Last updated
2015-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Modification

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.

Interventions

OTHERBroccoli and Brussels Sprouts
DIETARY_SUPPLEMENTCruciferous Complete
OTHERPlacebo

Sponsors

Standard Process Inc.
CollaboratorINDUSTRY
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Urinary 2:16 ratio8 weeksUrinary 2:16 ratios between treatment groups.

Secondary

MeasureTime frameDescription
Urinary 4OHE1 and 4OHE28 weeksUrinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.

Other

MeasureTime frameDescription
Sub-study: Serum carotenoids and dietary intakeOne blood draw on one dayCorrelation between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene and dietary intake.
Body composition8 weeksAssociation between body composition, urinary 2:16 ratio, and urinary 4OHE metabolites.
Dietary Intake8 weeksAssociation between dietary intake, urinary 2:16 ratio, and urinary 4OHE metabolites.
Sub-study: Serum carotenoids and body compositionOne blood draw on one dayCorrelation between serum carotenoids and body composition.
Stability of urinary 2:16 ratio.8 weeksChange in the urinary 2:16 ratio over 8 weeks in the placebo group.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026