Pilot Study Using a Wireless Motility Capsule

University of Minnesota (UMN)

Status: Completed

Conditions: Food Selection

Treatments: Device: SmartPill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01102894

0903M60781

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Low fiber and High Fiber

Experimental group

Description:

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

Treatment:

Device: SmartPill