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The Effect of Hot Cereal on Digestive Health in Children

PepsiCo logo

PepsiCo

Status

Completed

Conditions

Subjective Measures of Digestive Health Post Consumption

Treatments

Other: Hot cereal contain 3 g dietary fiber

Study type

Interventional

Funder types

Industry

Identifiers

NCT02868515
PEP-1602

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

7 to 12 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Oatmeal containing beta-glucan
Experimental group
Description:
43 g cereal containing 3g fiber per serving
Treatment:
Other: Hot cereal contain 3 g dietary fiber

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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