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

Use our guide to learn which trials are right for you!

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.


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;
We found this trial at
1
site
Cambridge, Massachusetts 02138
?
mi
from
Cambridge, MA
Click here to add this to my saved trials