Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion.
研究概览
简要总结
Colorectal (CRC) cancer is the third most common cancer in the United States and its incidence is rising in younger populations. Diet seems to affect risk for CRC.
Many parts of our diet are processed and modified by the microbes or bacteria in our gut. There are many different types of bacteria in our gut, each one of us has a "community" of different types and amounts of each type.
When we eat flaxseeds, certain types of bacteria will process them - producing compounds that can then affect our body. How much of these compounds are produced by each person depends on the "community" of bacteria in the gut.
Flaxseed and in certain nuts contain lignans, compounds that may have health benefits. Gut bacteria can convert the lignans into biologically active compounds that in animal models prevent the development of colon cancer. The investigators will study how these biologically active compounds affect colon cell-signaling pathways important to colorectal cancer risk.
Results from our study will bridge the current knowledge from animal studies and epidemiologic studies and may help to inform approaches for future CRC prevention.
详细描述
Part 1 (Screening):
Potential participants submit a screening questionnaire for eligibility. Eligible participants will come for an orientation for Part 1. If they consent the study coordinator will measure their height and weight and give them all the materials to do the activities for Part 1.
- Stool sample
- Days 1-3: take a lignan pill for three days
- Day 3: 24-hour urine collection.
No all participants will be eligible for Part 2.
Part 2 (Trial):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-smoking men and women
- •ages 20-45 y
- •don't eat a lot of vegetables
排除标准
- •chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, HNPCC, familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy) and cancer (other than non-melanoma skin cancer);
- •pregnancy or lactation;
- •weight change greater than 4.5 kg within past year;
- •oral or IV antibiotic use within the past 3 months;
- •alcohol intake of >2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine, or 90 ml spirits);
- •dietary fiber intake >15 g/day;
- •abnormal renal, liver or metabolic test results at baseline;
- •inability to swallow pills;
- •contraindications to sigmoidoscopy;
- •regular use of prescription or over-the-counter medications, including oral contraceptives;
- •known allergy to nuts, seeds and flaxseed;
- •intention to relocate out of study area within next 12 months.
结局指标
主要结局
mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion.
时间窗: 60 days
次要结局
未报告次要终点