Pilot Study Using a Wireless Motility Capsule

Not Applicable

Completed

• Conditions: Food Selection
• Interventions: Device: SmartPill

• Registration Number: NCT01102894
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-03-24
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Results First Submitted: 2013-02-07
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-15
• Results First Posted: 2014-10-27
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low fiber and High Fiber	SmartPill	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

Primary Outcome Measures

Name	Time	Method
Whole Gut Transit Time	5 days	The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerance	Day 4	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.
Food Intake Diary	Day 1	Total dietary fiber consumed.

Trial Locations

Locations (1)

University of Minnesota - McNeal Hall; 🇺🇸 St. Paul, Minnesota, United States