Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

Study Overview
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Brief Summary
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In recent years, the importance of the gut microbiota to human health has been demonstrated. In adulthood, the microbial profile is relatively stable, yet can be transiently altered by factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut microbiota has been shown to differ in normal versus disease states including inflammatory bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship, there is intense interest in designing interventions that positively influence the gut microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that alter the colonic environment in favour of health-promoting bacterial species, such as bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to beneficially alter the microbial profile, there is a need to identify the dosing requirements to positively modulate the gut microbiota. This study will test the effect of two doses of prebiotic on gut microbiota taxonomy and diversity.

Detailed Description
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The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d) or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to a non-prebiotic containing control. The primary outcome is change in microbial composition (measured via 16S rRNA sequencing). The secondary outcomes are change in gastrointestinal (GI) tolerance (measured via questionnaire); change in fecal short chain fatty acids; and change in quality of life. This study will consist of two separate trials of 12 week duration. Each trial will be performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week intervention period followed by a 4 week wash-out period and final 4 week cross over.

Official Title
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Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects who are regular snack consumers Not obese (BMI ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2) 18 and 65 years of age Stable bodyweight for at least 3-months prior to the study. Exclusion Criteria: Chronic disease including but not limited to type 1 or 2 diabetes, cardiovascular disease, liver or pancreas disease. Major gastrointestinal surgery Pregnant or lactating Antibiotic use in the preceding 3 months Currently consume probiotic or prebiotics supplements Currently consume more than 15 g/d of fiber in women and 18 g/d in men Are following a diet or exercise regime designed for weight loss Have a BMI greater than 29.9 kg/m2. Subjects who are required to start an antibiotic regime during the study will be withdrawn.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover design with 4 week washout period.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Isocaloric food without the test prebiotic. | Dietary Supplement: Control<br>* Isocaloric food without the test prebiotic.<br>|
| Experimental: Prebiotic<br>Prebiotic consumed as one daily serving of 7 g in Group 1 and consumed as one daily serving of 2.5-3 g in Group 2. | Dietary Supplement: Prebiotic<br>* Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline fecal bifidobacteria at 4 weeks | Assessed with 16S rRNA sequencing. | 4 weeks in cross-over design | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline fecal short chain fatty acid concentrations at 4 weeks | Analyzed with gas chromatography/mass spectrophotometry | 4 weeks in cross-over design | 
| Change in baseline gastrointestinal tolerance at 4 weeks | Analyzed with questionnaire | 4 weeks in cross-over design | 
| Change in baseline quality of life rating at 4 weeks | Measured with SF-36 questionnaire | 4 weeks in cross-over design | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prebiotic, Gut microbiota, Dietary fiber, Gastrointestinal tolerance