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Completed

NCT Number: NCT01102894

Pilot Study 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.

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Key information

Conditions

Food Selection Behavior Feeding Behavior Food Preferences

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota - McNeal Hall

Saint Paul, Minnesota, 55108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmartPill

Device

SmartPill

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Food Intake Diary

    Time frame: Day 1

    Total dietary fiber consumed.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • General Mills

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2010
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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