Subjective Measures of Digestive Health Post ConsumptionNCT02868515
The Effect of Hot Cereal on Digestive Health in Children
A study testing Hot cereal contain 3 g dietary fiber in people with Subjective Measures of Digestive Health Post Consumption, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
The objective of this study is to examine the effects of 2 servings of hot cereal per day over 2 weeks on digestive health in children that typically eat low fiber diets. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Measures of Digestive Health Post Consumption
- What is being tested?
- Hot cereal contain 3 g dietary fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 15 Nov 2016
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between the ages of 7-12 yrs.
- Low fiber eater (<14 g/d)
- Accustomed to eating breakfast at home
- Demonstrates spoken and written English literacy
- Parent/or legal guardian has experience using a cell phone camera
- Parent/or legal guardian is capable of emailing and texting photos by using cell phone features that enable this such as the select and attach option
- Able to provide assent with parent and/or legal guardian after review of study protocol and procedures
- Parent and/or legal guardian will also be required to provide consent on behalf of the child after reviewing study protocol and procedures
Who cannot join
- Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
- Use of fiber supplements such as fiber gummies (inulin/chicory root), or Metamucil or Citrucel
- Use of vitamin/mineral supplements, multivitamins, or herbal supplements.
- Participation in any other clinical trial up to 6 months before day 1 of participation in this study
- History of medical or surgical events that may significantly affect the study outcomes including diagnosed gastric or digestive diseases
- Not a regular breakfast eater at home
Show all 9Show fewer
- High-fiber eater (>14 g of fiber per day)
- Allergies to any of the ingredients in the test products
- Children taking medication that affects appetite (i.e. certain ADHD medications that depress appetite)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Clinical Trial to Assess the Effect of Hot Cereal on Digestive Health in Children
The objective of this study is to examine the effects of 2 servings of hot cereal per day over 2 weeks on digestive health in children that typically eat low fiber diets.
Read the detailed description
Participant eligibility will be screened at visit 1. The study will be a single-arm intervention design. The study procedures will include a pre-study visit, a pre-intervention baseline data collection period, a 14 day intervention period, and an end of study visit.
- Being tested
- Hot cereal contain 3 g dietary fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot cereal contain 3 g dietary fiberOther
Intervention involves consumption of a hot cereal over 14 day period
| Study group | Role | What they receive |
|---|---|---|
| Oatmeal containing beta-glucan | Experimental | 43 g cereal containing 3g fiber per serving Receives: Other: Hot cereal contain 3 g dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self reported frequency scales to questionnaire regarding digestive regularity
Measured: 2 weeks
Secondary outcomes (1)
Gastrointestinal tolerance
Using questionnaires
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjective Measures of Digestive Health Post ConsumptionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868515
- Sponsor's protocol ID
- PEP-1602
- Status last verified
- Jul 2017
- First submitted
- 14 Jun 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Paruzynski H, Korczak R, Wang Q, Slavin J. A Pilot and Feasibility Study of Oatmeal Consumption in Children to Assess Markers of Bowel Function. J Med Food. 2020 May;23(5):554-559. doi: 10.1089/jmf.2019.0158. Epub 2019 Oct 14.
PubMed 31613706
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Effect of Hot Cereal on Digestive Health in Children
- ClinicalTrials.gov ID
- NCT02868515
- Acronym / sponsor ID
- PEP-1602
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 16 Aug 2016 (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 objective of this study is to examine the effects of 2 servings of hot cereal per day over 2 weeks on digestive health in children that typically eat low fiber diets.
Detailed description
Participant eligibility will be screened at visit 1. The study will be a single-arm intervention design. The study procedures will include a pre-study visit, a pre-intervention baseline data collection period, a 14 day intervention period, and an end of study visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oatmeal containing beta-glucan | Experimental | Other: Hot cereal contain 3 g dietary fiber43 g cereal containing 3g fiber per serving |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Between the ages of 7-12 yrs.
- Low fiber eater (<14 g/d)
- Accustomed to eating breakfast at home
- Demonstrates spoken and written English literacy
- Parent/or legal guardian has experience using a cell phone camera
Key exclusion criteria (9 listed)
- Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
- Use of fiber supplements such as fiber gummies (inulin/chicory root), or Metamucil or Citrucel
- Use of vitamin/mineral supplements, multivitamins, or herbal supplements.
- Participation in any other clinical trial up to 6 months before day 1 of participation in this study
- History of medical or surgical events that may significantly affect the study outcomes including diagnosed gastric or digestive diseases
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 |
|---|---|---|
| Hot cereal contain 3 g dietary fiberIntervention involves consumption of a hot cereal over 14 day period | Other | Oatmeal containing beta-glucan |
Primary outcome
Self reported frequency scales to questionnaire regarding digestive regularity
Time frame: 2 weeks
1 secondary outcome
Gastrointestinal tolerance
Time frame: 2 weeks
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 21 Jul 2017.
- Derived from this study: PubMed 31613706Paruzynski H, Korczak R, Wang Q, Slavin J. A Pilot and Feasibility Study of Oatmeal Consumption in Children to Assess Markers of Bowel Function. J Med Food. 2020 May;23(5):554-559. doi: 10.1089/jmf.2019.0158. Epub 2019 Oct 14.
- Individual participant dataSharing planned: No
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.
Joanne Slavin, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot cereal contain 3 g dietary fiber in people with Subjective Measures of Digestive Health Post Consumption, run by PepsiCo Global R&D 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 8 inclusion and 9 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 21 Jul 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. 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?
Self reported frequency scales to questionnaire regarding digestive regularity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868515, which also lists 1 linked publication.
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 21 Jul 2017.