Study Focus is to Define the Usual Gut Microbiota Following Prebiotic FeedingNCT01277445
Effects of Fructan Prebiotics on the Intestinal Microbiota
A study testing Prebiotic in people with Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding, run by Dan Ramdath at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Prebiotic
- Keywords
- gut microbiome, prebiotics, immunological status, fructans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Inulin-fructan 15mg/day for 28days
PrebioticDietary supplement
Daily consumption of 15g inulin-fructan for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 15g/day maltodextrin for 28 days Receives: Dietary Supplement: Prebiotic |
| Prebiotic | Active comparator | Consumption of 15g/day of inulin-fructan for 28 days Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Secondary outcomes (1)
Blood lipids
Blood samples will be used to assess cardiovascular disease profiles and standard biochemical biomarkers
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Study Focus is to Define the Usual Gut Microbiota Following Prebiotic FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Ramdath
- Sponsor type
- Other government
- Collaborators
- Health Canada, Advance Foods and Materials Network, University of Ontario Institute of Technology, University of Lethbridge
- Responsible party
- Sponsor-investigator, Dan Ramdath, Guelph Food Research Centre
- Investigators
- Dan Ramdath, PhD, Study director, Guelph Food Research CentreMartin Kalmokoff, PhD, Study director, Agriculture and Agri-Food CanadaSteven Traplin, MD, Study director, Nutrasource Diagnostic IncMaggie Laidlaw, PhD, Principal investigator, Nutrasource Diagnostic Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277445
- Sponsor's protocol ID
- 01B46-10-0156
- Other IDs
- NDI: 2510.10
- Status last verified
- Mar 2015
- First submitted
- 14 Jan 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Fructan Prebiotics on the Intestinal Microbiota in Humans: Human Clinical Feeding Trial.
- ClinicalTrials.gov ID
- NCT01277445
- Acronym / sponsor ID
- 01B46-10-0156
- Keywords
- gut microbiome, prebiotics, immunological status, fructans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dan RamdathOther government
- Collaborators
- Health Canada, Advance Foods and Materials Network, University of Ontario Institute of Technology, University of Lethbridge
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Prebiotic15g/day maltodextrin for 28 days |
| Prebiotic | Active comparator | Dietary Supplement: PrebioticConsumption of 15g/day of inulin-fructan for 28 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticInulin-fructan 15mg/day for 28days | Dietary supplement | Placebo |
| PrebioticDaily consumption of 15g inulin-fructan for 28 days | Dietary supplement | Placebo, Prebiotic |
Primary outcome
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.
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.
1 secondary outcome
Blood lipids
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- BackgroundGourgue-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Ramdath, PhD study director
Guelph Food Research Centre
Martin Kalmokoff, PhD study director
Agriculture and Agri-Food Canada
Steven Traplin, MD study director
Nutrasource Diagnostic Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding, run by Dan Ramdath at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01277445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.