Effects of Fructan Prebiotics on the Intestinal Microbiota

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Effects of Fructan Prebiotics on the Intestinal Microbiota in Humans: Human Clinical Feeding Trial.

Conditions
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Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding

Intervention / Treatment
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* Dietary Supplement: Prebiotic
* Dietary Supplement: Prebiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>15g/day maltodextrin for 28 days | Dietary Supplement: Prebiotic<br>* Inulin-fructan 15mg/day for 28days<br>Dietary Supplement: Prebiotic<br>* Daily consumption of 15g inulin-fructan for 28 days<br>|
| Active Comparator: Prebiotic<br>Consumption of 15g/day of inulin-fructan for 28 days | Dietary Supplement: Prebiotic<br>* Daily consumption of 15g inulin-fructan for 28 days<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prebiotics, gut microbiome, immunological status, fructans