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Effects of Dietary Fiber on Gastrointestinal Function

This study is currently recruiting participants.
Verified December 2011 by National Starch LLC
Sponsor:
Information provided by (Responsible Party):
National Starch LLC
ClinicalTrials.gov Identifier:
NCT01495182
First received: December 14, 2011
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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 (Subject)
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:

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

Further study details as provided by National Starch LLC:

Primary Outcome Measures:
  • Gastrointestinal tolerability [ Time Frame: subjects will report weekly for 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Fecal weight and stool characteristics will be measured


Estimated Enrollment: 26
Study Start Date: December 2011
Estimated Primary Completion Date: July 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.

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495182

Contacts
Contact: Cathy Maki, RN, MSN 630-858-4419 cmaki@providentcrc.com
Contact: Kevin Maki, PhD 630-858-4400 kmaki@providentcrc.com

Locations
United States, Illinois
Provident Clinical Research and Consulting Inc Recruiting
Glen Ellyn, Illinois, United States, 60137
Contact: Cathy Maki, RN MSN     630-858-4419     cmaki@providentcrc.com    
Principal Investigator: Kevin Maki, PhD            
Sponsors and Collaborators
National Starch LLC
Investigators
Principal Investigator: Kevin Maki, PhD Provident Clinical Research Center
  More Information

Additional Information:
Study center recruitment  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: National Starch LLC
ClinicalTrials.gov Identifier: NCT01495182     History of Changes
Other Study ID Numbers: 002
Study First Received: December 14, 2011
Last Updated: December 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by National Starch LLC:
Dietary fiber
Gastrointestinal toleration
Fecal weight

ClinicalTrials.gov processed this record on May 16, 2013