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.
2 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 10, 2015
March 1, 2015
2 months
January 14, 2011
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Blood lipids
28 days
Study Arms (2)
Placebo
PLACEBO COMPARATOR15g/day maltodextrin for 28 days
Prebiotic
ACTIVE COMPARATORConsumption of 15g/day of inulin-fructan for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dan Ramdathlead
- Health Canadacollaborator
- Advance Foods and Materials Networkcollaborator
- University of Ontario Institute of Technologycollaborator
- University of Lethbridgecollaborator
Study Sites (1)
Nutrasoource Diagnostic Inc
Guelph, Ontario, N1G 0B4, Canada
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 17, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2013
Last Updated
March 10, 2015
Record last verified: 2015-03