A Study to Evaluate the Effect of Diet on the Tolerability of FOS in Healthy Volunteers

Study Overview
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Brief Summary
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The primary objective of this study is to determine the 5-day tolerability of one commercially available prebiotic food ingredient, FOS, in healthy human subjects with and without diet control.

Official Title
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An Open-label Study to Evaluate the Effect of Diet on the Tolerability of FOS, a Commercially Available Prebiotic, in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: FOS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be able to give written informed consent; Be male or female of any race, between 18 and 65 years of age; Have a BMI > 20 & < 27 kg/m2; Be willing to follow a controlled low fiber diet for a period of 11 days; Exclusion Criteria: Are less than 18 and greater than 65 years of age; Are hypersensitive to any of the components of FOS; Are currently taking probiotic or prebiotic supplements, or have taken them in the past 28 days; Unwilling to avoid probiotics/prebiotics supplements for the duration of the study; Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgment, entry to the study; Subject is a smoker; Subject has a history of drug and/or alcohol abuse at the time of enrollment; Taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial; Subjects may not be receiving treatment involving experimental drugs; If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study;

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fructooligosaccharide (FOS)<br>Subjects will be required to take 8 grams of FOS per day for a total of 10 days. | Dietary Supplement: FOS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events |  | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of controlling diet on the tolerability of FOS by analyzing the gut microbiome |  | 22 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prebiotic, FOS, fructooligosaccharide, polyglycan, microbiome, microbiota, Healthy Volunteers