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

NCT ID: NCT02628678

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fructooligosaccharide (FOS)

Subjects will be required to take 8 grams of FOS per day for a total of 10 days.

Group Type: OTHER

FOS

Intervention Type: DIETARY_SUPPLEMENT

Interventions

FOS

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaleido Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaleido Biosciences

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

G006-HU-PD

Identifier Type: -

Identifier Source: org_study_id