Healthy
Conditions
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).
Interventions
DIETARY_SUPPLEMENTFiber
OTHERPlacebo (low fiber bar)
Sponsors
Warren Bishop
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool frequency | 4 months | Weekly stool frequency will be compared between baseline and study end in each group |
| Change in stool consistency | 4 months | Stool consistency (using the Bristol scale) will be compared between baseline and study end in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed