Pilot Study Using a Wireless Motility Capsule

University of Minnesota10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Masking

SINGLE

Enrollment

Conditions

Food Selection

Interventions

SmartPillDEVICE

SmartPill

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota - McNeal Hall

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Whole Gut Transit Time

The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.

Time frame: 5 days

Secondary Outcomes

Gastrointestinal Tolerance

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.

Time frame: Day 4

Food Intake Diary

Total dietary fiber consumed.

Time frame: Day 1

Data from ClinicalTrials.gov

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