Subjective Measures of Digestive Health Post Consumption
Conditions
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.
Interventions
OTHERHot cereal contain 3 g dietary fiber
Intervention involves consumption of a hot cereal over 14 day period
Sponsors
PepsiCo Global R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self reported frequency scales to questionnaire regarding digestive regularity | 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance | 2 weeks | Using questionnaires |
Countries
United States
Outcome results
None listed