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

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.

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