Effects of Dietary Fiber on Gastrointestinal Function

Not Applicable

Completed

• Conditions: Gastrointestinal Health
• Interventions: Other: Dietary fiber

• Registration Number: NCT01495182
• Lead Sponsor: Ingredion Incorporated

Brief Summary

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

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 Timeline

• Status Verified: 2011-12
• Study Start: 2011-12
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dietary Fiber - Dose 1	Dietary fiber	Dietary fiber will be added to study foods
Dietary Fiber - Dose 2	Dietary fiber	Dietary fiber will be added to study foods
Control	Dietary fiber	Study foods with no added fiber will be given

Primary Outcome Measures

Name	Time	Method
Gastrointestinal tolerability	subjects will report weekly for 6 weeks	Questionnaire to assess symptoms such as nausea, bloating, and flatulence

Secondary Outcome Measures

Name	Time	Method
Fecal output	subjects will collect fecal output for 12 days within a six-week period	Fecal weight and stool characteristics will be measured

Trial Locations

Locations (1)

Provident Clinical Research and Consulting Inc; 🇺🇸 Glen Ellyn, Illinois, United States