NCT01495182

Effects of Dietary Fiber on Gastrointestinal Function

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ingredion Incorporated · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastrointestinal Health

Interventions

Type	Name	Description
OTHER	Dietary fiber	A proprietary fiber will be given to subjects

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-12-19
• Last updated: 2016-04-21

Locations

1 site across 1 country: United States