Effects of Dietary Fiber on Gastrointestinal Function

Ingredion

Status: Completed

Conditions: Gastrointestinal Health

Treatments: Other: Dietary fiber

Study type: Interventional

Funder types: Industry

Identifiers

NCT01495182

002

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 3 patient groups

Dietary Fiber - Dose 1

Experimental group

Description:

Dietary fiber will be added to study foods

Treatment:

Other: Dietary fiber

Dietary Fiber - Dose 2

Experimental group

Description:

Dietary fiber will be added to study foods

Treatment:

Other: Dietary fiber

Control

Active Comparator group

Description:

Study foods with no added fiber will be given

Treatment:

Other: Dietary fiber