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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: FOS

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Kaleido Biosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Fructooligosaccharide (FOS); Subjects will be required to take 8 grams of FOS per day for a total of 10 days.	Dietary supplement: FOS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
The effect of FOS on each subject's gut microbiome	22 days

Collaborators and Investigators

• Sponsor: Kaleido Biosciences

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (ESTIMATE): December 11, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Prebiotic; Healthy Volunteers; microbiome; microbiota; FOS; polyglycan; fructooligosaccharide
• Other Study ID Numbers: G006-HU-PD