Brassica Intake and Isothiocyanate Absorption: Intake Patterns May Have Implications for Cancer Prevention by Dietary Brassica Vegetables
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Total isothiocyanates (ITC)
研究概览
简要总结
Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3 weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of typical American foods and will be free of Brassica vegetables and free of glucosinolates and isothiocyanates. The Brassica diet will contain the control diet plus glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between study periods. Blood, urine, and fecal samples will be collected at the end of each study period. Eligible participants will be selected based on genotype for glutathione S-transferase (GST), which has been shown to influence the potential protective role of dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half (n=9) will have the GSTM1-null genotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 21 - 70 years of age
- •Not currently taking glucosinolate/ITC containing supplements
- •Voluntarily agree to participate and sign an informed consent document
- •Free of cancer (never diagnosed or cancer-free for at least 5 y)
排除标准
- •Pregnant, lactating, or intend to become pregnant during the study period
- •Known allergy or intolerance to Brassica vegetables
- •History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
- •Use of tobacco products
- •Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
- •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)
- •Unable or unwilling to give informed consent or communicate with study staff
- •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)
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
结局指标
主要结局
Total isothiocyanates (ITC)
时间窗: 24-hr
At the end of each study period, total ITC equivalents will be measured in blood and urine over a 24-hour period.
次要结局
- Gastrointestinal health(8-hr)
- Fecal microbiota(End of 3-week study period)
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center