Gastrointestinal Health
Conditions
Keywords
Dietary fiber, Gastrointestinal toleration, Fecal weight
Brief summary
The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.
Detailed 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.
Interventions
OTHERDietary fiber
A proprietary fiber will be given to subjects
Sponsors
Ingredion Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerability | subjects will report weekly for 6 weeks | Questionnaire to assess symptoms such as nausea, bloating, and flatulence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal output | subjects will collect fecal output for 12 days within a six-week period | Fecal weight and stool characteristics will be measured |
Countries
United States
Outcome results
None listed