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

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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.

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.

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)
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-7234
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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