Trial | NCT01277445  Report issue

Title

Effects of Fructan Prebiotics on the Intestinal Microbiota
Evaluation of the Effects of Fructan Prebiotics on the Intestinal Microbiota in Humans: Human Clinical Feeding Trial.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    inulin ...

  • Study Participants

    28
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.
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.
Study Started
Jan 31
2011
Primary Completion
Mar 31
2011
Study Completion
Mar 31
2013
Last Update
Mar 10
2015
Estimate

Dietary Supplement Prebiotic

Inulin-fructan 15mg/day for 28days

Dietary Supplement Prebiotic

Daily consumption of 15g inulin-fructan for 28 days

Placebo Placebo Comparator

15g/day maltodextrin for 28 days

Prebiotic Active Comparator

Consumption of 15g/day of inulin-fructan for 28 days

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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.
BMI >30
No Results Posted