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Pilot Study Using a Wireless Motility Capsule

This study has been completed.
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01102894
First received: March 24, 2010
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Food Selection
Device: SmartPill

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Whole Gut Transit Time [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.


Secondary Outcome Measures:
  • Gastrointestinal Tolerance [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Total dietary fiber consumed.


Enrollment: 10
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 <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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102894

Locations
United States, Minnesota
University of Minnesota - McNeal Hall
St. Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
General Mills Inc.
Investigators
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01102894     History of Changes
Other Study ID Numbers: 0903M60781
Study First Received: March 24, 2010
Results First Received: February 7, 2013
Last Updated: October 27, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2014