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Effects of Dietary Fiber on Gastrointestinal Function

This study has been completed.
Information provided by (Responsible Party):
National Starch LLC Identifier:
First received: December 14, 2011
Last updated: April 20, 2016
Last verified: December 2011
The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

Condition Intervention
Gastrointestinal Health
Other: Dietary fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by National Starch LLC:

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

Secondary Outcome Measures:
  • 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

Enrollment: 26
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01495182

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

Responsible Party: National Starch LLC Identifier: NCT01495182     History of Changes
Other Study ID Numbers: 002
Study First Received: December 14, 2011
Last Updated: April 20, 2016

Keywords provided by National Starch LLC:
Dietary fiber
Gastrointestinal toleration
Fecal weight processed this record on May 25, 2017