NCT01944579已完成不适用
Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria
Janet Novotny2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2013年9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
- 46
- 试验地点
- 2
- 主要终点
- Change in fecal microbiota
研究概览
简要总结
Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-75 years old
排除标准
- •Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
- •Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
- •Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
- •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 or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) 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 (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
- •Use of any tobacco products in past 3 months
- •Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
- •Known (self-reported) allergy or adverse reaction to blackberries or other study foods
- •Unable or unwilling to give informed consent or communicate with study staff
- •Self-report of alcohol or substance abuse within the past twelve 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 in fecal microbiota
时间窗: 0 weeks, 4 weeks
Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.
次要结局
- Change in blackberry nutrients & metabolites(0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes)
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center
研究点 (2)
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