Effects of Dietary Fiber on Gastrointestinal Function

Gastrointestinal Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495182
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• First received: December 14, 2011
• Last updated: April 20, 2016
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2011
• Source: National Starch LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 54 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastrointestinal Health

Intervention

Other:
• Dietary fiber
A proprietary fiber will be given to subjects

Locations

Country	Name	City	State
United States	Provident Clinical Research and Consulting Inc	Glen Ellyn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Starch LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal tolerability	Questionnaire to assess symptoms such as nausea, bloating, and flatulence	subjects will report weekly for 6 weeks	No
Secondary	Fecal output	Fecal weight and stool characteristics will be measured	subjects will collect fecal output for 12 days within a six-week period	No