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
  Purpose

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.


Condition Intervention
Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding
Dietary Supplement: Prebiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of the Effects of Fructan Prebiotics on the Intestinal Microbiota in Humans: Human Clinical Feeding Trial.

Further study details as provided by Guelph Food Research Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: March 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
15g/day maltodextrin for 28 days
Dietary Supplement: Prebiotic
Inulin-fructan 15mg/day for 28days
Dietary Supplement: Prebiotic
Daily consumption of 15g inulin-fructan for 28 days
Active Comparator: Prebiotic
Consumption of 15g/day of inulin-fructan for 28 days
Dietary Supplement: Prebiotic
Daily consumption of 15g inulin-fructan for 28 days

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277445

Locations
Canada, Ontario
Nutrasoource Diagnostic Inc
Guelph, Ontario, Canada, N1G 0B4
Sponsors and Collaborators
Dan Ramdath
Health Canada
Advance Foods and Materials Network
University of Ontario Institute of Technology
University of Lethbridge
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dan Ramdath, Research Scientist, Guelph Food Research Centre
ClinicalTrials.gov Identifier: NCT01277445     History of Changes
Other Study ID Numbers: 01B46-10-0156, NDI: 2510.10
Study First Received: January 14, 2011
Last Updated: February 22, 2012
Health Authority: Canada: Health Canada and Public Health Agency of Canada

Keywords provided by Guelph Food Research Centre:
gut microbiome
prebiotics
immunological status
fructans

Additional relevant MeSH terms:
Levan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014