Clinical trial NCT01277445: Effects of Fructan Prebiotics on the Intestinal Microbiota
Official title: Evaluation of the Effects of Fructan Prebiotics on the Intestinal Microbiota in Humans: Human Clinical Feeding Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding
Keywords: gut microbiome
prebiotics
immunological status
fructans
Lead sponsor: Guelph Food Research Centre
Sponsor class: OTHER_GOV
Collaborators: name: Health Canada
name: Advance Foods and Materials Network
name: University of Ontario Institute of Technology
name: University of Lethbridge
First posted: 2011-01-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Changes in gut microbiota
timeFrame: 28 days
measure: Changes in Immunological Status
timeFrame: 28 days
Secondary outcomes:
measure: Blood lipids
timeFrame: 28 days
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasoource Diagnostic Inc
state: Ontario
Study officials:
affiliation: Guelph Food Research Centre
name: Dan Ramdath, PhD
role: STUDY_DIRECTOR
affiliation: Agriculture and Agri-Food Canada
name: Martin Kalmokoff, PhD
role: STUDY_DIRECTOR
affiliation: Nutrasource Diagnostic Inc
name: Steven Traplin, MD
role: STUDY_DIRECTOR
affiliation: Nutrasource Diagnostic Inc
name: Maggie Laidlaw, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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