Pilot Study Using a Wireless Motility Capsule

NCT ID: NCT01102894

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-04-30

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.

Conditions

Food Selection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

Low fiber and High Fiber

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

Group Type: EXPERIMENTAL

SmartPill

Intervention Type: DEVICE

SmartPill

Interventions

SmartPill

SmartPill

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Mills

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanne L Slavin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota - McNeal Hall

Saint Paul, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21138605 (View on PubMed)

Other Identifiers

0903M60781

Identifier Type: -

Identifier Source: org_study_id