Bioavailability Study of Phenolics in Hemp Hull Dietary Fiber
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Blood concentration of phenolics from 0 to 8 hours
研究概览
简要总结
The aim is to determine the bioavailability of the polyphenol fraction form a commercially available hemp hull fiber at two different amounts in generally healthy adults. Additional objectives include determining specific metabolites produced over a 24 to 48-hour period following the hemp fiber consumption. Subjects will consume a study pudding that will be used to deliver a low and a high dose fiber product. Blood samples will be collected to measure background levels of metabolites. At day 0 participants will consume a low dose study product and day 6 the high dose study product and provide blood samples over an 8 hr period after study product consumption, to be followed by a 24 hr blood sample and 48 hr blood sample. Additionally following the low / high dose study product 24 and 48 h urine samples will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.50 - 29.99
- •non Tobacco or vaping user
- •non-user of hemp products within 12 months of first visit
- •Willing to stop dietary supplement use within 7 days of visit
- •Generally heathy
排除标准
- •History or presence of clinically important disorders that may affect subjects ability to participate in the study
- •Clinically important GI conditions that potentially interfere with evaluation of study product
- •Uncontrolled hypertension or unstable use of antihypertensives
- •Recent antibiotic use
- •extreme dietary habits
- •recent or currently on weight loss regimen
- •Known allergy or sensitivity to the study products
- •History or presence of cancer in prior 2 years, except for non-melanoma skin cancer
- •History of any major trauma or major surgical event within 2 months of first visit
- •Pregnancy or willing to become pregnant during study
- •Alcohol abuses
- •Exposure to any non-registered drug product within 30 days prior to first visit
结局指标
主要结局
Blood concentration of phenolics from 0 to 8 hours
时间窗: 0 to 8 hours after consumption
次要结局
- Concentration of Phenolic metabolites in blood and urine(Blood concnetrations at 0 to 8 hours post consumption and cumulative urine concentration 24 hours and 48 hours post consumption)
- Urine concentration of phenolics 24 and 48 hours after consumption(cumulative total phenolics at 24 and 48 hours)
- Blood concentration of phenolics 0 to 24 hours(0 to 24 hours after consumption)