A Clinical Trial to Assess the Efficacy of a Supplemental Formula Targeting Breast Health in Beneficially Altering Urinary Estrogen Metabolites Levels in Both Pre- and Post-menopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- 2-OH Hydroxy Estrone: 16-alpha-OH Estrone
研究概览
简要总结
The purpose of this study is to determine if a supplemental formula can beneficially alter the ratio of urinary estrogen metabolites.
详细描述
The active botanical constituents in femMED Breast Health Formula contain lignans, compounds with anti-estrogenic activity, that have been shown to exert an estrogenic effect during the follicular phase [i.e. when estrogen is low] and an antiestrogenic effect in the luteal phase of a female menstrual cycle. These are plant-derived chemicals that can act as weak mimics of estrogen in the body. Overall these compounds have been found to be helpful in stabilizing the natural cyclical fluctuation of estrogen levels.
The trial will be a double-blind, placebo-controlled parallel study in which 100 subjects will be recruited to one of two arms of the study: one arm will consist of pre-menopausal women; another will consist of post-menopausal women. Each arm of the study will be carried out concurrently and in one phase, with no washout period. The placebo assignment will be randomized within each arm of the study.
Subjects in each arm of the study will follow the same protocol. Urine and blood samples will be collected from each group at both the first and last visit, and subjects will receive a month's supply of treatment or placebo at the first visit, which they will consume on a daily basis until their second lab visit 28 days later. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. Blood samples would be collected and assessed for levels of enterolactone. Pre and post-supplementation results will be assesses for any differences by statistical comparison.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Willing to collect urine samples and to have blood drawn
- •Post-menopausal and have not taken hormone replacement therapy (HRT) in the past year (48 subjects)
- •Pre-menopausal (48 subjects)
排除标准
- •Diagnosed with any major illness(e.g. cancer)
- •Diabetes, thyroid disease, atypical hyperplasia, fibrocystic breast disease, family history of ovarian cancer, a history of "migraines with aura"
- •Women taking blood thinner or thyroid medication (including warfarin)
- •Known allergy to any of the any of the study ingredients
- •Pregnancy or lactation
- •Regular consumption in the previous 3 months of any other natural health products (NHPs) or pharmaceutical containing ingredients with a similar effect on estrogen metabolism as those included in the femMED Breast Health treatment
- •Family history of breast cancer risk
- •Post-menopausal women on HRT
- •Pre-menopausal women taking hormonal contraceptives (oral contraceptives, the patch etc.)
- •All other forms of estrogen, progesterone and/or androgens (i.e. testosterone therapy)
结局指标
主要结局
2-OH Hydroxy Estrone: 16-alpha-OH Estrone
时间窗: Day 0, Day 28
2-OHE:16α-OHE1 (2:16 ratio) - 2:16 ratios less than 2.0 indicate increasing long-term risk for breast, cervical, and other estrogen sensitive cancers. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone.
次要结局
- Enterolactone(Day 0, Day 28)