A Pilot Study of the Flaxseed Effects on Hormones and Lignans: Role of Race, Genes, and Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)
研究概览
简要总结
This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.
详细描述
PRIMARY OBJECTIVES:
I. To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones.
II. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed).
III. To determine how these associations differ by race (i.e., African American and European American women).
OUTLINE: Participants are randomized to 1 of 2 treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- •Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged >= 55 years
- •Willingness to comply with the requirements of the study
排除标准
- •Unwilling or unable to follow protocol requirements
- •Self-reported race other than non-Hispanic white or non-Hispanic black
- •Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
- •Nut or seed allergy
- •Self-reported inflammatory bowel disease
- •Gastric bypass
- •Use of thyroid replacement medication (Synthroid or similar) for < 1 year
- •Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseed
- •Chemotherapy/radiation within the past year
- •Body weight greater than 400 pounds (limit of Tanita scale)
结局指标
主要结局
Steroid hormone and lignans levels after exposure to a lignan-rich food (flaxseed)
时间窗: Up to week 21
Relative percent of Eubacteria composition from quantitative polymerase chain reaction (qPCR) associated with lignan levels
时间窗: Up to week 21
次要结局
未报告次要终点