Pilot Study Using a Wireless Motility Capsule

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT01102894
• Collaborator: General Mills (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Food Selection	Device: SmartPill	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Official Title: Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: SmartPill; SmartPill

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Food Intake Diary [Day 1]

   Total dietary fiber consumed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota - McNeal Hall	St. Paul	Minnesota	United States	55108

Sponsors and Collaborators

• University of Minnesota
• General Mills

Investigators

• Principal Investigator: Joanne L Slavin, PhD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01102894
• Other Study ID Numbers: 0903M60781
• First Posted: Apr 13, 2010
• Last Update Posted: Nov 4, 2014
• Last Verified: Oct 1, 2014

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the University of Minnesota via fliers on the St. Paul campus
Pre-assignment Detail	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.

Arm/Group Title	High Fiber and Low Fiber
Arm/Group Description	Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Low Fiber and High Fiber
Arm/Group Description	Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber SmartPill : SmartPill
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24 (2)
Sex: Female, Male (Count of Participants)
Female	5 50%
Male	5 50%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Whole Gut Transit Time
Description	The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

All participants had their transit time assessed.

Arm/Group Title	High Fiber	Low Fiber
Arm/Group Description	Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill	Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Measure Participants	10	10
Mean (Standard Deviation) [hours]	22.5 (14.6)	31.4 (5.8)

2. Secondary Outcome

Title	Gastrointestinal Tolerance
Description	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

Outcome Measure Data

Analysis Population Description

Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.

Arm/Group Title	High Fiber	Low Fiber
Arm/Group Description	Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill	Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	9.5 (1.7)	6.8 (1.7)

3. Secondary Outcome

Title	Food Intake Diary
Description	Total dietary fiber consumed.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake

Arm/Group Title	High Fiber	Low Fiber
Arm/Group Description	Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill	Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Measure Participants	10	10
Mean (Standard Deviation) [g]	14 (7.5)	15 (7)

Adverse Events

Time Frame	Study length
Adverse Event Reporting Description	No Adverse events were recorded during the study
Arm/Group Title	High Fiber		Low Fiber
Arm/Group Description	Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill		Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
All Cause Mortality
	High Fiber		Low Fiber
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	High Fiber		Low Fiber
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	High Fiber		Low Fiber
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.