Pilot Study Using a Wireless Motility Capsule

October 27, 2014 updated by: University of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • St. Paul, Minnesota, United States, 55108
        • University of Minnesota - McNeal Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low fiber and High Fiber
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
SmartPill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole Gut Transit Time
Time Frame: 5 days
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
Time Frame: 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.
Day 4
Food Intake Diary
Time Frame: Day 1
Total dietary fiber consumed.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

General Mills

Investigators

  • Principal Investigator: Joanne L Slavin, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 0903M60781

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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