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Effects of Dietary Fiber on Gastrointestinal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01495182
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Gastrointestinal Health Other: Dietary fiber

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women
Study Start Date : December 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Gastrointestinal tolerability [ Time Frame: subjects will report weekly for 6 weeks ]
    Questionnaire to assess symptoms such as nausea, bloating, and flatulence

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495182

United States, Illinois
Provident Clinical Research and Consulting Inc
Glen Ellyn, Illinois, United States, 60137
Sponsors and Collaborators
Ingredion Incorporated
Principal Investigator: Kevin Maki, PhD Provident Clinical Research Center
More Information

Responsible Party: Ingredion Incorporated
ClinicalTrials.gov Identifier: NCT01495182     History of Changes
Other Study ID Numbers: 002
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: December 2011

Keywords provided by Ingredion Incorporated:
Dietary fiber
Gastrointestinal toleration
Fecal weight