Effects of Dietary Fiber on Gastrointestinal Function

April 20, 2016 updated by: Ingredion Incorporated

A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women

The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Glen Ellyn, Illinois, United States, 60137
        • Provident Clinical Research and Consulting Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy men and women
  • age 18 - 54 years
  • BMI < 30 kg/m2

Exclusion Criteria:

  • presence of GI or other serious diseases known to affect GI function
  • recent use of antibiotics
  • very high fiber intake
  • use of medications known to affect GI function
  • presence of allergies to study foods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary Fiber - Dose 1
Dietary fiber will be added to study foods
Other: Dietary fiber
A proprietary fiber will be given to subjects
Experimental: Dietary Fiber - Dose 2
Dietary fiber will be added to study foods
Other: Dietary fiber
A proprietary fiber will be given to subjects
Active Comparator: Control
Study foods with no added fiber will be given
Other: Dietary fiber
A proprietary fiber will be given to subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal tolerability
Time Frame: subjects will report weekly for 6 weeks
Questionnaire to assess symptoms such as nausea, bloating, and flatulence
subjects will report weekly for 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal output
Time Frame: subjects will collect fecal output for 12 days within a six-week period
Fecal weight and stool characteristics will be measured
subjects will collect fecal output for 12 days within a six-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ingredion Incorporated

Investigators

  • Principal Investigator: Kevin Maki, PhD, Provident Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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