Brown Seaweed as a Breast Cancer Preventive
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Thyroid hormones affected by dietary seaweed and soy supplements
研究概览
简要总结
Japanese postmenopausal women in Japan have about one ninth the rate of American postmenopausal women. Rates of breast cancer double even after just ten years among Japanese women who migrate to the US. Diet is thought to be an important factor, and the investigators were interested in whether dietary seaweed, with and without soy supplements, could influence known biomarkers of breast cancer risk in American women.
详细描述
33 healthy postmenopausal women were randomized to 6 wk seaweed then 1 wk seaweed plus soy or 6 wk placebo then 1 wk placebo plus soy. Blood and urine samples were collected at the end of each treatment period and analyzed for estrogen, homocysteine, antioxidants, insulin-like growth factors and thyroid hormones. Urine was analyzed for phytoestrogens and iodine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal (self-reported cessation of menstruation 1 y prior to enrollment)
- •If breast cancer survivor, all therapy completed at least 6 months prior to enrollment
- •Agreed to eat their normal diet, avoiding seaweeds and phytoestrogen-rich foods,
- •Restricting alcoholic intake to #2 drinks (24 g alcohol)/wk -Continuing habitual intake of vitamins, supplements, and medications during the study. -
排除标准
- •No allergies to seaweed, soy, shellfish, or iodine
- •No current use of tobacco;
- •No thyroid dysfunction or treatment within the previous 5 y;
- •Negative thyroid peroxidase antibodies as determined by screening;
- •No hormone replacement therapy or for breast cancer survivors, no chemotherapy or radiation treatments within the preceding 6 mo
- •No history of cancer (other than breast cancer)
- •No current gastrointestinal disorders or diabetes; omnivorous eating habits, including meat and dairy products at least twice/wk
- •No oral antibiotics, iodine containing medications, or corticosteroids treatment within the previous 3 mo.
结局指标
主要结局
Thyroid hormones affected by dietary seaweed and soy supplements
时间窗: 14 weeks
6 wk seaweed followed by 1 wk seaweed plus soy; Or 6 wk placebo followed by 1 wk soy 3 wk washout period then crossover to alternate arm
次要结局
- Serum IGF-1 and IGFBP3 changes associated with seaweed and soy supplementation(14 wk)
- Serum antioxidant and homocysteine concentrations associated with seaweed and soy(14 wks)
- Serum estrogen and urinary phytoestrogen concentrations affected by seaweed and soy(14 wks)
研究者
Jane Teas
Professor
University of South Carolina