The Effect of Hot Cereal on Digestive Health in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Trial to Assess the Effect of Hot Cereal on Digestive Health in Children

Conditions
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Subjective Measures of Digestive Health Post Consumption

Intervention / Treatment
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* Other: Hot cereal contain 3 g dietary fiber


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported frequency scales to questionnaire regarding digestive regularity |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Using questionnaires | 2 weeks |