Effects of Dietary Fiber on Gastrointestinal Function

Ingredion Incorporated26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Gastrointestinal Health

Interventions

Dietary fiberOTHER

A proprietary fiber will be given to subjects

Eligibility

Sex: ALLMin age: 18 YearsMax age: 54 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Provident Clinical Research and Consulting Inc

Glen Ellyn, Illinois, United States

Outcomes

Primary Outcomes

Gastrointestinal tolerability

Questionnaire to assess symptoms such as nausea, bloating, and flatulence

Time frame: subjects will report weekly for 6 weeks

Secondary Outcomes

Fecal output

Fecal weight and stool characteristics will be measured

Time frame: subjects will collect fecal output for 12 days within a six-week period

Data from ClinicalTrials.gov

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