Pilot Study Using a Wireless Motility Capsule

Study Overview
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Brief Summary
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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.

Detailed Description
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The ability of a device to track gastrointestinal transit time, including gastric emptying time, was measured in healthy people consuming low and high fiber diets.

Official Title
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Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule

Conditions
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Food Selection

Intervention / Treatment
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* Device: SmartPill


Participation Criteria
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Eligibility Criteria
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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 <18 or >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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low fiber and High Fiber<br>Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time | Device: SmartPill<br>* SmartPill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Gut Transit Time | The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance | Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value. | Day 4 | 
| Food Intake Diary | Total dietary fiber consumed. | Day 1 |