Food Selection
Conditions
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.
Interventions
DEVICESmartPill
SmartPill
Sponsors
General Mills
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole Gut Transit Time | 5 days | The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance | Day 4 | 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. |
| Food Intake Diary | Day 1 | Total dietary fiber consumed. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the University of Minnesota via fliers on the St. Paul campus
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Low Fiber and High Fiber |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Population: All participants had their transit time assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fiber | Whole Gut Transit Time | 22.5 hours | Standard Deviation 14.6 |
| Low Fiber | Whole Gut Transit Time | 31.4 hours | Standard Deviation 5.8 |
Secondary
Food Intake Diary
Total dietary fiber consumed.
Time frame: Day 1
Population: Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fiber | Food Intake Diary | 14 g | Standard Deviation 7.5 |
| Low Fiber | Food Intake Diary | 15 g | Standard Deviation 7 |
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.
Time frame: Day 4
Population: Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fiber | Gastrointestinal Tolerance | 9.5 units on a scale | Standard Deviation 1.7 |
| Low Fiber | Gastrointestinal Tolerance | 6.8 units on a scale | Standard Deviation 1.7 |