Effects of Dietary Fiber on Gastrointestinal Function

Study Overview
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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.

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.

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

Conditions
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Gastrointestinal Health

Intervention / Treatment
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* Other: Dietary fiber


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Fiber - Dose 1<br>Dietary fiber will be added to study foods | Other: Dietary fiber<br>* A proprietary fiber will be given to subjects<br>|
| Experimental: Dietary Fiber - Dose 2<br>Dietary fiber will be added to study foods | Other: Dietary fiber<br>* A proprietary fiber will be given to subjects<br>|
| Active Comparator: Control<br>Study foods with no added fiber will be given | Other: Dietary fiber<br>* A proprietary fiber will be given to subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerability | Questionnaire to assess symptoms such as nausea, bloating, and flatulence | subjects will report weekly for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal output | Fecal weight and stool characteristics will be measured | subjects will collect fecal output for 12 days within a six-week period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary fiber, Gastrointestinal toleration, Fecal weight