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.

Study Overview

• Status: Completed
• Conditions: Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding
• Intervention / Treatment: Dietary supplement: Prebiotic; Dietary supplement: Prebiotic

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
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 0B4
      • Nutrasoource Diagnostic Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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; Inulin-fructan 15mg/day for 28days; Dietary supplement: Prebiotic; Daily consumption of 15g inulin-fructan for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gut microbiota	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.	28 days
Changes in Immunological Status	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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipids	Blood samples will be used to assess cardiovascular disease profiles and standard biochemical biomarkers	28 days

Collaborators and Investigators

• Sponsor: Dan Ramdath
• Collaborators: Health Canada; Advance Foods and Materials Network; University of Lethbridge; University of Ontario Institute of Technology
• 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: gut microbiome; prebiotics; fructans; immunological status
• Other Study ID Numbers: 01B46-10-0156; NDI: 2510.10 (Other Grant/Funding Number: Agriculture and Agri-Food Canada)