Health Benefits and Tolerance of Dietary Fiber Supplements in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Warren Bishop
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in stool consistency
Study Overview
Brief Summary
The investigators hypothesize that fiber supplementation will provide measurable differences in indices of children's health (fewer complaints of abdominal pain and constipation, lower body mass index) compared to placebo.
Detailed Description
This prospective study proposes supplementing children with fiber or placebo for four months. Children in elementary school, ages 5-12, will be randomized to receive fiber supplemented bars vs low-fiber snack bars (placebo).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children bewteen ages of 5-12 years
Exclusion Criteria
- •History of allergy/intolerance to components of the snack bars (e.g. celiac disease)
- •History of Hisrchsprungs disease, abdominal surgery to intestine or colon
- •Unable to take a fiber bar by mouth
Arms & Interventions
Fiber
Intervention: Fiber (Dietary Supplement)
Placebo
Intervention: Placebo (low fiber bar) (Other)
Outcomes
Primary Outcomes
Change in stool consistency
Time Frame: 4 months
Stool consistency (using the Bristol scale) will be compared between baseline and study end in each group
Change in stool frequency
Time Frame: 4 months
Weekly stool frequency will be compared between baseline and study end in each group
Secondary Outcomes
- Change in quality of life score(4 months)
- Change in weight(4 months)
Investigators
Warren Bishop
MD
University of Iowa