Fiber Health Benefits

September 26, 2017 updated by: Warren Bishop

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 4 months
Weekly stool frequency will be compared between baseline and study end in each group
4 months
Change in stool consistency
Time Frame: 4 months
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
Time Frame: 4 months
Weight will be measured and compared between baseline and study end in each group
4 months
Change in quality of life score
Time Frame: 4 months
Pediatric Quality of Life Survey (PedsQL) score will compared between baseline and study end in each group
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warren Bishop

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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