Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| General Mills | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartPill | Device | SmartPill |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Food Intake Diary |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joanne L Slavin, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota - McNeal Hall | Saint Paul | Minnesota | 55108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21138605 | Derived | 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. |
Not provided
Not provided
Exclusion criteria included contraindicated conditions for the SmartPill: dysphasia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, previous gastrointestinal surgery, implanted electro-mechanical medical devices, and medications shown to influence gastrointestinal transit time.
Subjects were recruited from the University of Minnesota via fliers on the St. Paul campus
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High Fiber and Low Fiber | Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low Fiber and High Fiber | Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber SmartPill : SmartPill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whole Gut Transit Time | The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces. | All participants had their transit time assessed. | Posted | Mean | Standard Deviation | hours | 5 days |
|
Study length
No Adverse events were recorded during the study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Fiber | Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne Slavin | University of Minnesota | 612-624-7234 | jslavin@umn.edu |
Not provided
| ID | Term |
|---|---|
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Total dietary fiber consumed. |
| Day 1 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Each participant completed a gastrointestinal tolerance questionnaire during each treatment period. | Posted | Mean | Standard Deviation | units on a scale | Day 4 |
|
|
|
| Secondary | Food Intake Diary | Total dietary fiber consumed. | Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake | Posted | Mean | Standard Deviation | g | Day 1 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Low Fiber | Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill | 0 | 10 | 0 | 10 |
Not provided
Not provided