Effects of Dietary Fiber on Gastrointestinal Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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

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Gastrointestinal Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Dietary Fiber - Dose 1

Dietary fiber will be added to study foods

Group Type EXPERIMENTAL

Dietary fiber

Intervention Type OTHER

A proprietary fiber will be given to subjects

Dietary Fiber - Dose 2

Dietary fiber will be added to study foods

Group Type EXPERIMENTAL

Dietary fiber

Intervention Type OTHER

A proprietary fiber will be given to subjects

Control

Study foods with no added fiber will be given

Group Type ACTIVE_COMPARATOR

Dietary fiber

Intervention Type OTHER

A proprietary fiber will be given to subjects

Interventions

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Dietary fiber

A proprietary fiber will be given to subjects

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes