The Effect of Hot Cereal on Digestive Health in Children

July 19, 2017 updated by: PepsiCo Global R&D

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oatmeal containing beta-glucan
43 g cereal containing 3g fiber per serving
Other: Hot cereal contain 3 g dietary fiber
Intervention involves consumption of a hot cereal over 14 day period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self reported frequency scales to questionnaire regarding digestive regularity
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal tolerance
Time Frame: 2 weeks
Using questionnaires
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

November 15, 2016

Study Completion (Actual)

November 15, 2016

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • PEP-1602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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