NCT01102894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

October 27, 2014

Completed
Last Updated

November 4, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

March 24, 2010

Results QC Date

February 7, 2013

Last Update Submit

October 27, 2014

Conditions

Food Selection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Gastrointestinal Tolerance

    Day 4

  • Food Intake Diary

    Day 1

Study Arms (1)

Low fiber and High Fiber

EXPERIMENTAL

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

Device: SmartPill

Interventions

SmartPillDEVICE

SmartPill

Low fiber and High Fiber

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota - McNeal Hall

Saint Paul, Minnesota, 55108, United States

Location

Related Publications (1)

  • 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.

    PMID: 21138605DERIVED

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Limitations and Caveats

The study interventions were not randomized, which doesn't allow for period effect calculations. The SmartPill can reside in the stomach for longer than a few hours, which can skew results.

Results Point of Contact

Title
Dr. Joanne Slavin
Organization
University of Minnesota
jslavin@umn.edu
612-624-7234

Study Officials

  • Joanne L Slavin, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2010

First Posted

April 13, 2010

Study Start

August 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

November 4, 2014

Results First Posted

October 27, 2014

Record last verified: 2014-10

Locations

US(1)