Fiber Health Benefits
- Conditions
- Healthy
- Registration Number
- NCT02177864
- Lead Sponsor
- Warren Bishop
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-Children bewteen ages of 5-12 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in stool consistency 4 months Stool consistency (using the Bristol scale) will be compared between baseline and study end in each group
Change in stool frequency 4 months Weekly stool frequency will be compared between baseline and study end in each group
- Secondary Outcome Measures
Name Time Method Change in weight 4 months Weight will be measured and compared between baseline and study end in each group
Change in quality of life score 4 months Pediatric Quality of Life Survey (PedsQL) score will compared between baseline and study end in each group
Related Research Topics
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Trial Locations
- Locations (1)
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Iowa🇺🇸Iowa City, Iowa, United States