The Effect of Hot Cereal on Digestive Health in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-11-15

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.

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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.

Conditions

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Subjective Measures of Digestive Health Post Consumption

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Oatmeal containing beta-glucan

43 g cereal containing 3g fiber per serving

Group Type EXPERIMENTAL

Hot cereal contain 3 g dietary fiber

Intervention Type OTHER

Intervention involves consumption of a hot cereal over 14 day period

Interventions

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Hot cereal contain 3 g dietary fiber

Intervention involves consumption of a hot cereal over 14 day period

Intervention Type OTHER

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)

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes