NCT02177864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

June 24, 2014

Last Update Submit

September 26, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change in weight

    4 months

  • Change in quality of life score

    4 months

Study Arms (2)

Fiber

EXPERIMENTAL
Dietary Supplement: Fiber

Placebo

PLACEBO COMPARATOR
Other: Placebo (low fiber bar)

Interventions

FiberDIETARY_SUPPLEMENT
Fiber
Placebo (low fiber bar)OTHER
Placebo

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children bewteen ages of 5-12 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Warren Bishop, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 30, 2014

Study Start

April 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

US(1)