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CompletedNCT02868515Updated Jul 21, 2017

The Effect of Hot Cereal on Digestive Health in Children

An interventional study of Hot cereal contain 3 g dietary fiber in Subjective Measures of Digestive Health Post Consumption, sponsored by PepsiCo Global R&D. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by PepsiCo Global R&D · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
7 Years to 12 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Subjective Measures of Digestive Health Post Consumption
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Oatmeal containing beta-glucan

    43 g cereal containing 3g fiber per serving

    Other: Hot cereal contain 3 g dietary fiber

Interventions

  • OtherHot cereal contain 3 g dietary fiber

    Intervention involves consumption of a hot cereal over 14 day period

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What researchers measure

Primary outcomes

  1. Self reported frequency scales to questionnaire regarding digestive regularity

    Time frame: 2 weeks

Secondary outcomes

  1. Gastrointestinal tolerance

    Using questionnaires

    Time frame: 2 weeks

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02868515
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Aug 16, 2016
Start date
Jun 2016
Primary completion
Nov 15, 2016
Completion
Nov 15, 2016
Last update
Jul 21, 2017

Study contacts

Joanne Slavin, PhD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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