NCT01293617已完成不适用
Blackberry Intake and Biomarkers of Cancer Risk
United States Department of Agriculture (USDA)2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from baseline in 8-oxo-dG levels after 5 days
研究概览
简要总结
Berry components have been shown to influence cancer processes in cell culture studies. The investigators will conduct a study to investigate if blackberries influence the same cancer processes in a human feeding study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking men and women
- •Aged 40-75
- •BMI 19-38 kg/m2
排除标准
- •Younger then 40 ears old or older than 75 years old
- •BMI less than 19 or greater than 38
- •Use of blood-thinning medications such as warfarin, dicumarol, or anisinidione
- •Presence of kidney disease, liver disease, gout, certain cancers, untreated thyroid, gastrointestinal, other metabolic diseases or malabsorption syndromes
- •Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- •Fasting triglycerides greater than 300 mg/dL
- •Fasting glucose greater than 126 mg/dL
- •History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g. vegetarians, very low fat diets, high protein diets)
- •Use of prescription of over-the-counter antiobesity medications or supplements during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
- •Active cardiovascular disease
- •Use of any tobacco products in the past 6 months
- •Use of oral or IV antibiotics during the month preceding the study or during the study
- •Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the start of the study
- •Known (self-reported) allergy or adverse reaction to blackberries or gelatin
- •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
Change from baseline in 8-oxo-dG levels after 5 days
时间窗: Day 5
次要结局
未报告次要终点
研究者
研究点 (2)
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