Fiber Health Benefits

Health Benefits and Tolerance of Dietary Fiber Supplements in Children

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Fiber; Other: Placebo (low fiber bar)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo (low fiber bar)
Experimental: Fiber	Dietary supplement: Fiber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	4 months

Collaborators and Investigators

• Sponsor: Warren Bishop

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Actual): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 201202731

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No