Effects of Fructan Prebiotics on the Intestinal Microbiota

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Guelph Food Research Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Health Canada
Advance Foods and Materials Network
University of Ontario Institute of Technology
University of Lethbridge
Information provided by (Responsible Party):
Dan Ramdath, Guelph Food Research Centre
ClinicalTrials.gov Identifier:
NCT01277445
First received: January 14, 2011
Last updated: February 22, 2012
Last verified: February 2012

January 14, 2011
February 22, 2012
January 2011
March 2011   (final data collection date for primary outcome measure)
  • Changes in gut microbiota [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.
  • Changes in Immunological Status [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01277445 on ClinicalTrials.gov Archive Site
Blood lipids [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Blood samples will be used to assess cardiovascular disease profiles and standard biochemical biomarkers
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding
  • Dietary Supplement: Prebiotic
    Inulin-fructan 15mg/day for 28days
  • Dietary Supplement: Prebiotic
    Daily consumption of 15g inulin-fructan for 28 days
  • Placebo Comparator: Placebo
    15g/day maltodextrin for 28 days
    Interventions:
    • Dietary Supplement: Prebiotic
    • Dietary Supplement: Prebiotic
  • Active Comparator: Prebiotic
    Consumption of 15g/day of inulin-fructan for 28 days
    Intervention: Dietary Supplement: Prebiotic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
March 2013
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01277445
01B46-10-0156, NDI: 2510.10
No
Dan Ramdath, Guelph Food Research Centre
Dan Ramdath
  • Health Canada
  • Advance Foods and Materials Network
  • University of Ontario Institute of Technology
  • University of Lethbridge
Study Director: Dan Ramdath, PhD Guelph Food Research Centre
Study Director: Martin Kalmokoff, PhD Agriculture and Agri-Food Canada
Study Director: Steven Traplin, MD Nutrasource Diagnostic Inc
Principal Investigator: Maggie Laidlaw, PhD Nutrasource Diagnostic Inc
Guelph Food Research Centre
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP