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OpenTrials
Completed

NCT Number: NCT02177864

Fiber Health Benefits

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.

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Key information

Conditions

Healthy

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fiber

Dietary Supplement

Placebo (low fiber bar)

Other

Primary outcomes

  1. Change in stool frequency

    Time frame: 4 months

    Weekly stool frequency will be compared between baseline and study end in each group

  2. 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

Secondary outcomes

  1. Change in weight

    Time frame: 4 months

    Weight will be measured and compared between baseline and study end in each group

  2. 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

Sponsors and collaborators

Lead sponsor

Warren Bishop

Other

Registry information

Official study title

Health Benefits and Tolerance of Dietary Fiber Supplements in Children

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2014
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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