Trial | NCT01495182  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    26
The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.
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 Started
Dec 31
2011
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Apr 21
2016
Estimate

Other Dietary fiber

A proprietary fiber will be given to subjects

Dietary Fiber - Dose 1 Experimental

Dietary fiber will be added to study foods

Dietary Fiber - Dose 2 Experimental

Dietary fiber will be added to study foods

Control Active Comparator

Study foods with no added fiber will be given

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
No Results Posted