NCT02868515

Completed

The Effect of Hot Cereal on Digestive Health in Children

PepsiCo Global R&D Source

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Other study identifiers

Sponsor study identifier

PEP-1602

Study Type

interventional

Actual enrollment (reported)

20

Locations

1 country

Sites

1

Timeline

Study Start

June 2016

Actual (reported)

Primary Completion

November 15, 2016

Actual (reported)

Study Completion

November 15, 2016

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 20 participants
Study completion date: November 15, 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2016
Actual (reported)
First Submitted
June 14, 2016
Actual (reported)
First Posted
August 16, 2016
Actual (reported)
Primary Completion
November 15, 2016
Actual (reported)
Study Completion
November 15, 2016
Actual (reported)

Last Updated: July 21, 2017
Status Verified: July 2017
Last Update Submitted: July 19, 2017

Conditions

Subjective Measures of Digestive Health Post Consumption

Outcome Measures

Primary Outcomes (1)

Self reported frequency scales to questionnaire regarding digestive regularity
2 weeks

Secondary Outcomes (1)

Gastrointestinal tolerance
2 weeks

Study Arms (1)

Oatmeal containing beta-glucan

EXPERIMENTAL

43 g cereal containing 3g fiber per serving

Other: Hot cereal contain 3 g dietary fiber

Interventions

Hot cereal contain 3 g dietary fiberOther

Intervention involves consumption of a hot cereal over 14 day period

Oatmeal containing beta-glucan

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age7 Years - 12 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Between the ages of 7-12 yrs.
Low fiber eater (\<14 g/d)

Sponsors & Collaborators

PepsiCo Global R&D
Industrylead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Related Publications (1)

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.
PMID: 31613706DERIVED

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

Joanne Slavin, PhD
University of Minnesota
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 14, 2016

First Posted

August 16, 2016

Study Start

June 2016

Actual (reported)

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Primary Completion

November 15, 2016

Actual (reported)

Study Completion

November 15, 2016

Actual (reported)

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02868515
Data provider: ClinicalTrials.gov
Source updated: 2017-07-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:45 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Oatmeal containing beta-glucan

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations