Food SelectionNCT01102894

Pilot Study Using a Wireless Motility Capsule

A study testing SmartPill in people with Food Selection, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Food Selection
What is being tested?: SmartPill
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Apr 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy men and women
Age 18 - 65
Non-smoking
Not taking medication
Non-dieting
BMI 18-30
English literacy
Ability to swallow the SmartPill

Who cannot join

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

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota - McNeal Hall
Saint Paul, Minnesota, 55108

Other trials in United States

About this study

Official title: Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule

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.

Read the 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
Being tested: SmartPill
Medical subject headings: Food Preferences

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SmartPillDevice
SmartPill

Study groups in NCT01102894
Study group	Role	What they receive
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 Receives: Device: SmartPill

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: Day 4
Food Intake Diary
Total dietary fiber consumed.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Apr 2010

First posted13 Apr 2010 (estimated)
Study startAug 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Food SelectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Not applicable
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01102894
Sponsor's protocol ID: 0903M60781
Status last verified: Oct 2014
First submitted: 24 Mar 2010
Last updated: 4 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21138605

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements
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Influence of Social Media Ads on Food Choice - Master Protocol
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Optimization Trial to Empower sElection of Nutritious Foods
Food Insecurity, Healthy Eating
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Food Menu Labelling Effects on Individuals With Eating Disorders and Other Mental Health Conditions.
Food Labelling, Eating Behaviour
Recruiting
Healthy Options At Pantries (HOAP) Study
Food Choice, Implementation Science

All Food Selection trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule
ClinicalTrials.gov ID: NCT01102894
Acronym / sponsor ID: 0903M60781
Conditions: Food Selection
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: General Mills
Study start: Aug 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 13 Apr 2010 (estimated)
Results: Posted 27 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 1

Arm	Type	Receives
Low fiber and High Fiber	Experimental	Device: SmartPillSubjects 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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy men and women
Age 18 - 65
Non-smoking
Not taking medication
Non-dieting

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SmartPillSmartPill	Device	Low fiber and High Fiber

Primary outcome

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

2 secondary outcomes

Gastrointestinal Tolerance
Time frame: Day 4
Food Intake Diary
Time frame: Day 1

Results and safety

Results posted to the registry on 27 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Fiber and Low Fiber	10	10

Primary outcome: Whole Gut Transit Time

Time frame: 5 days. Mean (Standard Deviation). Unit: hours

Measure	High Fiber n = 10	Low Fiber n = 10
Value	22.5 (14.6)	31.4 (5.8)

Population analysed: All participants had their transit time assessed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study length. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Fiber	0 of 10 (0%)	0 of 10 (0%)	Not reported
Low Fiber	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21138605Timm 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.

Related trials for Food Selection

Not yet recruiting
Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements
GLP - 1
Recruiting
Influence of Social Media Ads on Food Choice - Master Protocol
Food Selection, Food Choices
Not yet recruiting
Optimization Trial to Empower sElection of Nutritious Foods
Food Insecurity, Healthy Eating
Not yet recruiting
Food Menu Labelling Effects on Individuals With Eating Disorders and Other Mental Health Conditions.
Food Labelling, Eating Behaviour
Recruiting
Healthy Options At Pantries (HOAP) Study
Food Choice, Implementation Science

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joanne L Slavin, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SmartPill in people with Food Selection, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole Gut Transit Time (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01102894, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.