HealthyNCT02177864
Fiber Health Benefits
A study testing Fiber in people with Healthy, run by Warren Bishop at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -Children bewteen ages of 5-12 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Fiber, Placebo (low fiber bar)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberDietary supplement
Placebo (low fiber bar)Other
| Study group | Role | What they receive |
|---|---|---|
| Fiber | Experimental | Not described Receives: Dietary Supplement: Fiber |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo (low fiber bar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool frequency
Weekly stool frequency will be compared between baseline and study end in each group
Measured: 4 months
Change in stool consistency
Stool consistency (using the Bristol scale) will be compared between baseline and study end in each group
Measured: 4 months
Secondary outcomes (2)
Change in weight
Weight will be measured and compared between baseline and study end in each group
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startApr 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warren Bishop
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Warren Bishop, University of Iowa
- Investigators
- Warren Bishop, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177864
- Sponsor's protocol ID
- 201202731
- Status last verified
- Sep 2017
- First submitted
- 24 Jun 2014
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Benefits and Tolerance of Dietary Fiber Supplements in Children
- ClinicalTrials.gov ID
- NCT02177864
- Acronym / sponsor ID
- 201202731
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Warren BishopUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber | Experimental | Dietary Supplement: Fiber |
| Placebo | Placebo comparator | Other: Placebo (low fiber bar) |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Children bewteen ages of 5-12 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiber | Dietary supplement | Fiber |
| Placebo (low fiber bar) | Other | Placebo |
Primary outcome
Change in stool frequency
Time frame: 4 months
Weekly stool frequency will be compared between baseline and study end in each group
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
2 secondary outcomes
Change in weight
Time frame: 4 months
Change in quality of life score
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Bishop, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber in people with Healthy, run by Warren Bishop at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool frequency (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.