NCT02299778已完成1 期
Is Bacterially-Synthesized Folate Absorbed Across the Colon of Humans?
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in isotopic folate overtime in blood
研究概览
简要总结
The purpose of this study is to determine whether folate produced by bacteria that live in our colon can be absorbed in human colon using a stable isotope method. This study would lead a better understanding of the bioavailability of colonic bacterially-synthesized folate and its quantitative contribution to whole body folate homeostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years;
- •overall healthy
排除标准
- •<18 years or >65 years
- •chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
- •regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. antiacids, laxatives, phenytoin, sulfasalzine, phenobarbital, primidone, cimetidine, proton pump inhibitors [such as Nexium] and antibiotics [such as Sulfonamides] or nonsteroidal anti-inflammatory drugs [NSAIDS, such as aspirin/ibuprofen])
- •consumption of >1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
- •planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
- •known sensitivity to sunscreens containing ultraviolet B filters and/or PABA
- •difficulty with swallowing large pills or providing venous blood samples
研究组 & 干预措施
1mg of 13C6-p-aminobenzoic acid
Experimental
干预措施: 13C6-p-aminobenzoic acid (Dietary Supplement)
结局指标
主要结局
Change in isotopic folate overtime in blood
时间窗: Baseline (day 1), Days 2-4 ( 0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
Change in isotopic folate overtime in urine
时间窗: Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)
次要结局
- Folate intake(Day1-4)
- Fiber intake(Day1-4)
研究者
Deborah O'Connor
Senior Associate Scienitst
The Hospital for Sick Children
研究点 (2)
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