Pilot Study Using a Wireless Motility Capsule

Completed · Not applicable

Conditions studied: Food Selection

In brief

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.

Key facts

Study ID

NCT01102894

Run by

University of Minnesota

People needed

10

Starts

2009-08-01

Expected to finish

2010-04-01

Last updated by the study team

2014-11-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women
• Age 18 - 65
• Non-smoking
• Not taking medication
• Non-dieting
• BMI 18-30
• English literacy
• Ability to swallow the SmartPill

You may not qualify if…

• 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

Where it is running

• University of Minnesota - McNeal Hall — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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