Effects of Fructan Prebiotics on the Intestinal Microbiota

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01277445
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : March 10, 2015
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

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.

Condition or disease Intervention/treatment Phase
Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding Dietary Supplement: Prebiotic Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of the Effects of Fructan Prebiotics on the Intestinal Microbiota in Humans: Human Clinical Feeding Trial.
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Changes in gut microbiota [ Time Frame: 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.

  2. Changes in Immunological Status [ Time Frame: 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.

Secondary Outcome Measures :
  1. Blood lipids [ Time Frame: 28 days ]
    Blood samples will be used to assess cardiovascular disease profiles and standard biochemical biomarkers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01277445

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
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

Additional Information:
Gourgue-Jeannot et al. 2006. Can. J. Microbiol. 52:924-933. Brooks et al. 2009. Anaerobe 15:145-154. Costa et al. 2009 J. Microbiol. Methods 78:175-180. Lupton et al. J Nutr. 2004 134:479-82. Gibson and Roberfroid. 1995. J Nutr. 125:1401-12. Parracho et al. 2007. Proc. Nutr Soc. 66:405-11. Eckburg et al. 2005. Science 308:1635-8. Brooks et al. 2003. Can J. Microbiol. 49:589-601. Kelly et al. 2005 Trends Immunol. 26:326-33. Liu et al. 2008. Proc Natl Acad Sci U S A. 105:3951-6. Tsuji et al. 2008. Semin Immunol. 20:59-66. Reigstad et al. 2009 PLoS One 4:e5842. Jenkins et al. 2005. Metabolism 54:103-12. Jenkins et al. 1999. J. Nutr. 129:1431S-1433S. Seidel et al, 2007. Br. J. Nutr. 97:349-356. DiPenta et al. 2007. Appl.Physiol. Nutr.Metabol. 32:1025-1035. Albers et al. 2005. Br. J. Nutr. 94:452-481. Suzuki et al. 2007. Sem. Imm. 19: 127-135. Macpherson et al. 2004. Science 303: 1662-1665. Maino et al. 2004. Clinical Immunol. 110: 222- 231. Coombes and Powrie 2008. Nature Reviews Immunology 8: 435-446. Bakkerk-Zierikzee et al. 2006. Pediatr Allergy Immunol 17:134-140. Svedlund et al. 1988. Digestive Dis. & Sci. 33:129-134. Francka et al., 2005. Allergy Immunol. 136:155-158.

Responsible Party: Dan Ramdath, Research Scientist, Guelph Food Research Centre Identifier: NCT01277445     History of Changes
Other Study ID Numbers: 01B46-10-0156
NDI: 2510.10 ( Other Grant/Funding Number: Agriculture and Agri-Food Canada )
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by Dan Ramdath, Guelph Food Research Centre:
gut microbiome
immunological status

Additional relevant MeSH terms:
Antineoplastic Agents