Evaluation of the Effects of Fructan Prebiotics on the Intestinal Microbiota in Humans: Human Clinical Feeding Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Changes in Immunological Status
研究概览
简要总结
Prebiotics are carbohydrate polymers believed to improve health by stimulating beneficial gastrointestinal microbial populations. Prebiotic health claims are currently not permitted in Canada due to a lack of validating scientific data. Currently, Health Canada considers 'prebiotic' to imply a health benefit that must be substantiated. Our goal is to conduct a human clinical trial to define the impacts of fructans on the colonic microbiome as well as the physiological, psychological and immunological effects on the host.
详细描述
Current health claims for the fructan prebiotics focus on the bifidogenic properties of these substrates. While these claims appear to be widely accepted among nutritionists, the gut-microbiology community considers this an archaic view on these complex communities which contain in excess of 400 species of which the majority have yet to be cultivated or characterized. The bifidogenic effect associated with fructans also forms the basis of current prebiotic health claims in Canada, claims which up until now have not stood up to regulatory scrutiny The primary objective of this study is to assess the impact of frucans on the human microbiome, as well as the physiological, immunological health of the host. Information generated from this study will address both aspects of the current FOA definition of what constitutes a "prebiotic". New data generated from this study will be applicable for a new health claim for prebiotics and will provide a guide for industry demonstrating the requirements for a scientifically valid study for other submissions involving prebiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 - 50 years
- •General good health
- •Participant understands the study procedures and provides informed consent (signed) to participate and authorizes the release of relevant protected health information to the study investigators
排除标准
- •History or presence of GI disorders (Irritable bowel syndrome, colitis, Crohn's disease, colon cancer or polyps)
- •Recent use of antibiotics
- •Regular use of high inulin containing food products.
- •Known intolerance or sensitivity to any ingredients in the study product.
结局指标
主要结局
Changes in Immunological Status
时间窗: 28 days
Circulating levels of cytokines associated with pro-inflammatory status and regulatory activity as well as those associated with TH1 and TH2 activity will be measured. Effects of fructans on cell population profiles in the immune system will also be determined from whole peripheral blood samples, using antibodies against B and T cells, T cell subsets, Natural Killer cells, monocytes, neutrophils and dendritic cells (DC), (including CD3, CD14, CD16, CD19, CD20, CD56)and analyzing by flow cytometry.
Changes in gut microbiota
时间窗: 28 days
various culture and non-culture methods, including molecular biology techniques will be used to determine the type and relative abundance of the gut microbione of persons fed a prebiotic compared with placebo.
次要结局
- Blood lipids(28 days)
研究者
Dan Ramdath
Research Scientist
Guelph Food Research Centre