The Role of the Gut Microbiota in Estrogen Metabolism and Dietary Flax as a Potential Modulator.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in gut microbiota diversity
研究概览
简要总结
The purpose of this pilot study is to determine if suppressing estrogen in premenopausal women results in changes in gut microbiota and if dietary flaxseed modulates these changes.
详细描述
This pilot study will begin to address whether gut microbiota change with estrogen suppression. Specifically, the investigators will test whether gut microbial diversity and abundance change in response to estrogen suppression and consumption of dietary flaxseed. To test this possibility the investigators will recruit premenopausal women (age 20-40 years old)and collect fecal samples before and after 1 month of estrogen suppression with GnRH agonist. The investigators will analyze the gut microbiota in response to estrogen loss and whether this differs with the consumption of flaxseed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Biological samples will be masked for endpoint analysis
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy premenopausal women (20-40 years)
- •normal to overweight (22-29.9 kg/m2)
- •normally menstruating (25-35 day cycles)
- •not have used estrogen-based contraception for >6 months.
- •sedentary to moderately active (exercise ≤120 min week-1)
- •must not be taking phytoestrogenic dietary supplements, or lipid- or glucose- lowering medications.
排除标准
- •pregnancy or breastfeeding
- •Hormonal contraceptive use (past 6 mo.)
- •Women with contraindications to GnRHAG:
- •History of fragility fracture
- •Low BMD (i.e., proximal femur or lumbar spine z scores < -2.0)
- •Abnormal vaginal bleeding
- •History of breast cancer or other estrogen-dependent neoplasms
- •History of venous thromboembolic events
- •Hypersensitivity to leuprolide acetate or benzyl alcohol (the vehicle for injection of leuprolide acetate)
- •Evidence for depressive symptoms (Score ≥ 18 on the Beck Depression Inventory, BDI)
- •Moderate or severe renal impairment defined as a calculated creatinine clearance <50 mL/min based on the equation of Cockcroft and Gault91
- •Chronic hepatobiliary disease, conservatively defined as liver function tests (AST, ALT, alkaline phosphatase, Total Bilirubin) >1.5 times the upper limit of normal (if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed)
- •antibiotic or probiotic use within 2 months of sample collection
结局指标
主要结局
Change in gut microbiota diversity
时间窗: At baseline (day 0) and 30 days after estrogen suppression, with and without dietary flaxseed 30 days before estrogen suppression and during the 30 days of estrogen suppression
16s rRNA sequencing--Illumina MiSeq
次要结局
- Estrogen metabolites(At baseline (day 0) and 30 days after estrogen suppression, with and without dietary flaxseed 30 days before estrogen suppression and during the 30 days of estrogen suppression)