Fiber Health Benefits

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Fiber; Other: Placebo (low fiber bar)

• 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).

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiber	Fiber	-
Placebo	Placebo (low fiber bar)	-

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

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States