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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiber | Dietary Supplement |
| ||
| Placebo (low fiber bar) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stool frequency | Weekly stool frequency will be compared between baseline and study end in each group | 4 months |
| Change in stool consistency | Stool consistency (using the Bristol scale) will be compared between baseline and study end in each group | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Weight will be measured and compared between baseline and study end in each group | 4 months |
| Change in quality of life score | Pediatric Quality of Life Survey (PedsQL) score will compared between baseline and study end in each group |
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Inclusion Criteria:
-Children bewteen ages of 5-12 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Bishop, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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|
| 4 months |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |