The Effect of Hot Cereal on Digestive Health in Children
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 7 - 12 |
Updated: | 8/17/2016 |
Start Date: | June 2016 |
End Date: | December 2016 |
Contact: | Joanne Slavin, PhD |
Email: | jslavin@umn.edu |
Phone: | 612-624-7234 |
A Clinical Trial to Assess the Effect of Hot Cereal on Digestive Health in Children
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.
over 2 weeks on digestive health in children that typically eat low fiber diets.
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.
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.
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)
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