Clinical trial NCT01102894: Pilot Study Using a Wireless Motility Capsule
Official title: Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2010-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Whole Gut Transit Time
timeFrame: 5 days
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Day 4
measure: Food Intake Diary
timeFrame: Day 1
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: University of Minnesota - McNeal Hall
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timm D, Willis H, Thomas W, Sanders L, Boileau T, Slavin J. The use of a wireless motility device (SmartPill(R)) for the measurement of gastrointestinal transit time after a dietary fibre intervention. Br J Nutr. 2011 May;105(9):1337-42. doi: 10.1017/S0007114510004988. Epub 2010 Dec 8.