N/A
N=10
Pilot Study Using a Wireless Motility Capsule
Food Selection
Bottom Line
View on ClinicalTrials.gov: NCT01102894 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Whole Gut Transit Time — 22.5; 31.4 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SmartPill (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Gut Transit Time |
22.5; 31.4 | — |
| SECONDARY Gastrointestinal Tolerance |
9.5; 6.8 | — |
| SECONDARY Food Intake Diary |
14; 15 | — |
Summary
Research suggests dietary fiber may decrease transit time through the gastrointestinal tract. Research studies traditionally use radio-opaque markers to determine gastric emptying, colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be used to determine gastric emptying, colonic transit, and whole gut transit time without requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and the SmartPill detect the similar transit times.
The purpose of this pilot study is to determine if the SmartPill can detect a change in transit time using a significant dose of dietary fiber.
Eligibility Criteria
Inclusion Criteria
- Healthy men and women
- Age 18 - 65
- Non-smoking
- Not taking medication
- Non-dieting
- BMI 18-30
- English literacy
- Ability to swallow the SmartPill
Exclusion Criteria
- Do not regularly consume breakfast
- Food allergies to ingredients fond in study products
- Dislike of hot cereal
- BMI 30
- Are not weight stable
- Diagnosed with diabetes, cardiovascular, renal, or hepatic disease
- Cancer in previous 5 years (except basal cell carinoma of the skin)
- Any gastrointestinal disease or condition
- Any gastrointestinal surgeries that alter motility
- Recent antibiotic usage (< 6 months)
- recent or concurrent participation in an intervention research study
- History of drug or alcohol abuse in prior 6 months
- Use of laxatives, anti-diarrheal, antacids, or medications which alter motility
- Vegetarians
- People who eat more than approximately 15 grams of fiber per day
- Currently consume fiber supplements
- Women who are pregnant or lactating
- Women with irregular menstrual cycles
Data sourced from ClinicalTrials.gov (NCT01102894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.