The Effect of Hot Cereal on Digestive Health in Children

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)