Pilot Study Using a Wireless Motility Capsule

Food Selection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102894
• Other study ID #: 0903M60781
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: October 27, 2014
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Food Selection

Intervention

Device:
• SmartPill
SmartPill

Locations

Country	Name	City	State
United States	University of Minnesota - McNeal Hall	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	General Mills Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Gut Transit Time	The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.	5 days	No
Secondary	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.	Day 4	No
Secondary	Food Intake Diary	Total dietary fiber consumed.	Day 1	No