A Study to Evaluate the Effect of Diet on the Tolerability of FOS in Healthy Volunteers
Status: | Active, not recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/21/2016 |
Start Date: | November 2015 |
End Date: | April 2016 |
An Open-label Study to Evaluate the Effect of Diet on the Tolerability of FOS, a Commercially Available Prebiotic, in Healthy Volunteers
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.
commercially available prebiotic food ingredient, FOS, in healthy human subjects with and
without diet control.
Inclusion Criteria:
1. Be able to give written informed consent;
2. Be male or female of any race, between 18 and 65 years of age;
3. Have a BMI > 20 & < 27 kg/m2;
4. Be willing to follow a controlled low fiber diet for a period of 11 days;
Exclusion Criteria:
1. Are less than 18 and greater than 65 years of age;
2. Are hypersensitive to any of the components of FOS;
3. Are currently taking probiotic or prebiotic supplements, or have taken them in the
past 28 days;
4. Unwilling to avoid probiotics/prebiotics supplements for the duration of the study;
5. Have a significant acute or chronic, unstable and untreated disease or any condition
which contraindicates, in the investigators judgment, entry to the study;
6. Subject is a smoker;
7. Subject has a history of drug and/or alcohol abuse at the time of enrollment;
8. 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;
9. 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;
10. Subjects may not be receiving treatment involving experimental drugs;
11. If the subject has been in a recent experimental trial, these must have been
completed not less than 60 days prior to this study;
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