The Effect of Hot Cereal on Digestive Health in Children

Not Applicable

Completed

• Conditions: Subjective Measures of Digestive Health Post Consumption
• Interventions: Other: Hot cereal contain 3 g dietary fiber

• Registration Number: NCT02868515
• Lead Sponsor: PepsiCo Global R&D

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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Primary Completion: 2016-11-15
• Study Completion: 2016-11-15
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oatmeal containing beta-glucan	Hot cereal contain 3 g dietary fiber	43 g cereal containing 3g fiber per serving

Primary Outcome Measures

Name	Time	Method
Self reported frequency scales to questionnaire regarding digestive regularity	2 weeks

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	2 weeks	Using questionnaires

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States