Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- CYP1A2 activity will be analyzed
研究概览
简要总结
The primary objective of this study is to determine how daily consumption of kale changes the activity of human xenobiotic metabolizing enzymes. Secondary objectives are to measure absorption and metabolism of kale phytonutrients, and to determine how kale consumption affects gene expression related to metabolism and lipid measures associated with cardiovascular health.
详细描述
Consumption of Brassica vegetables (which include broccoli, cabbage, and kale) is inversely associated with the incidence of several cancers, including cancers of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source of many nutrients, but the unique characteristic of Brassicas is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to bioactive metabolites by a plant enzyme called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds are considered to be the active agent for cancer prevention. Their ability to reduce risk of cancer may derive in part from their ability to modulate foreign-substance metabolizing enzymes, which include enzymes called Phase I cytochrome P450s and Phase II enzymes.
The primary aim of this study is to investigate how daily consumption of kale influences foreign-substance metabolizing enzymes, which in turn may reduce cancer risk. Secondary aims of this study include measuring metabolism of kale nutrients, effect of kale consumption on fecal microbiota, and how kale consumption influences risk factors for cardiovascular disease.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5 years cancer free
- •Not a tobacco product user
- •Blood glucose less than 126 mg/dL
- •Able to voluntarily agree to participate and sign an informed consent document
排除标准
- •Brassica vegetable allergy or intolerance
- •use of oral contraceptives
- •Women who have given birth in the previous 12 months
- •Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
- •Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
- •History of bariatric surgery or nutrient malabsorption disease
- •Pregnant, lactating, or intending to become pregnant during the study period
- •Crohn's disease or diverticulitis
- •Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- •Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
结局指标
主要结局
CYP1A2 activity will be analyzed
时间窗: Day 49
Plasma will be analyzed for caffeine metabolite ratios.
次要结局
- UGT1A1 activity will be analyzed(On days 7, 14, 42, and 49)
- Apolipoprotein A2(On days 0, 7, 14, 35, 42, and 49)
- Fecal microbiota will be analyzed for microbial DNA(Days 0, 14, 35, and 49)
- Total cholesterol(On days 0, 7, 14, 35, 42, and 49)
- Apolipoprotein A1(On days 0, 7, 14, 35, 42, and 49)
- The ability of fecal microbiota to metabolize glucosinolates will be determined(Days 14 and 49.)
- Metabolites of Kale(On days 35 and 36)
- Glutathione S-transferase alpha concentration(On days 7, 14, 42, and 49)
- LDL cholesterol(On days 0, 7, 14, 35, 42, and 49)
- HDL cholesterol(On days 0, 7, 14, 35, 42, and 49)
- Triacylglycerides(On days 0, 7, 14, 35, 42, and 49)
- Apolipoprotein B(On days 0, 7, 14, 35, 42, and 49)
- Changes in gene expression(On days 0, 14, 35, and 49)
研究者
Craig Charron
Research Molecular Biologist
USDA Beltsville Human Nutrition Research Center