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临床试验/NCT01726127
NCT01726127已完成不适用

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

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Urinary 2:16 ratio

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Urinary 2:16 > or =
  • 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.

结局指标

主要结局

Urinary 2:16 ratio

时间窗: 8 weeks

Urinary 2:16 ratios between treatment groups.

次要结局

  • Urinary 4OHE1 and 4OHE2(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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