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

NCT02628678 | Completed

• 1 other identifier: G006-HU-PD
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

Prebiotic; FOS; fructooligosaccharide; polyglycan; microbiome; microbiota; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Adverse Events

  22 days

Secondary Outcomes (1)

• The effect of controlling diet on the tolerability of FOS by analyzing the gut microbiome

  22 days

Other Outcomes (1)

• The effect of FOS on each subject's gut microbiome

  22 days

Study Arms (1)

Fructooligosaccharide (FOS)

OTHER

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

Dietary Supplement: FOS

Interventions

FOS DIETARY_SUPPLEMENT

Fructooligosaccharide (FOS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kaleido Biosciences: lead

Study Sites (1)

Kaleido Biosciences

Cambridge, Massachusetts, 02138, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 11, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

US (1)