University of Wisconsin Osteoporosis Clinical Research Program Clinic
Madison, Wisconsin, 53705, United States
NCT Number: NCT01726127
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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Notify Me40 year–50 year
Female
Interventional
Not applicable
Madison, Wisconsin, 53705, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 weeks
Urinary 2:16 ratios between treatment groups.
Time frame: 8 weeks
Urinary concentrations of 4-hydroxyestrone (4OHE1) and 4-hydroxyestradiol (4OHE2) between treatment groups.
Time frame: 8 weeks
Association between body composition, urinary 2:16 ratio, and urinary 4OHE metabolites.
Time frame: 8 weeks
Change in the urinary 2:16 ratio over 8 weeks in the placebo group.
Time frame: One blood draw on one day
Correlation between serum α-carotene, β-carotene, β-cryptoxanthin, lutein and lycopene and dietary intake.
Time frame: One blood draw on one day
Correlation between serum carotenoids and body composition.
Time frame: 8 weeks
Association between dietary intake, urinary 2:16 ratio, and urinary 4OHE metabolites.
University of Wisconsin, Madison
Other
Effect of Cruciferous Vegetables or a Cruciferous Supplement on Urinary Estrogen Metabolites in Premenopausal Women
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