Effect of Dietary Flaxseed on Circulating Sex Hormone Levels Among Post-menopausal Women - an Intervention Trial to Explore Flaxseed Intake as a Possible Breast Cancer Prevention Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period)
研究概览
简要总结
The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. This study will address the first steps toward the development of possible breast cancer prevention strategies. Differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).
详细描述
PRIMARY OBJECTIVES:
I. Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1&-E2, 4-MeOH-E1&-E2) thought to be involved in the development of breast cancer.
SECONDARY OBJECTIVES:
II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.
III. Describe adherence to the flaxseed intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 57 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1. Women residing in Toronto aged 57-64 years old, and post-menopausal.
排除标准
- •Consumers of flaxseed and soy (including supplements) in the past 6 months.
- •Consumers of sesame oil and sesame seeds in the past 6 months.
- •Women who took antibiotics orally in the past 6 months.
- •Women who took hormone replacement therapy or corticosteroids in the past month.
- •Non-English speaking.
- •Current chronic illnesses such as bowel disease (e.g. IBS - irritable bowel syndrome, or IBD - inflammatory bowel disease, such as Crohn's or ulcerative colitis), diabetes, heart disease (e.g. high cholesterol or high blood pressure and on medication for it), cancer, or another chronic illness.
- •Women who are currently taking blood thinners, such as Warfarin.
结局指标
主要结局
Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period)
时间窗: Day 0 and ~Day 50
次要结局
- Change in serum enterolignan levels at Day 0 (baseline) compared with ~Day 50 (end of study period)(Day 0 and ~Day 50)