Food SelectionNCT02667184
The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Healthy Human Subjects
A study testing Low FODMAP Oral Nutrition Supplement in people with Food Selection, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- Low FODMAP Oral Nutrition Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Between the ages of 18-65 years with a body mass index between 18-29 kg/m2.
- Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures.
Who cannot join
- Use of enemas, proton pump inhibitors, or antibiotics within the past 3 months
- Smoker
- Not a regular breakfast eater
- Self-reported history of a past or current gastrointestinal disease
- High fiber eater (> or = to 3 servings of high fiber foods per day)
- Concurrent or recent (within 30 days) participation in an intervention trial
- Recent weight fluctuations
- Allergies to any of the test products
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Health Human Subjects
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over a 4 hour time period.
Read the detailed description
This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen and methane analysis at various time points over a 4 hour time period. Subjects will also be asked to rate gastrointestinal symptoms via a questionnaire at various time points throughout the study.
- Conditions
- Food Selection
- Being tested
- Low FODMAP Oral Nutrition Supplement
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP Oral Nutrition SupplementDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP Oral Nutrition Supplement 1 | Experimental | Low FODMAP Oral Nutrition Supplement Receives: Dietary Supplement: Low FODMAP Oral Nutrition Supplement |
| Low FODMAP Oral Nutrition Supplement 2 | Experimental | Low FODMAP Oral Nutrition Supplement Receives: Dietary Supplement: Low FODMAP Oral Nutrition Supplement |
| Low FODMAP Oral Nutrition Supplement 3 | Experimental | Low FODMAP Oral Nutrition Supplement Receives: Dietary Supplement: Low FODMAP Oral Nutrition Supplement |
| FOS Supplement | Experimental | Supplement containing fructooligosaccharides Receives: Dietary Supplement: Low FODMAP Oral Nutrition Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath hydrogen response
At baseline, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon.
Measured: baseline
Breath hydrogen response
At 60 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon.
Measured: 60 minutes
Breath hydrogen response
At 120 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation.
Measured: 120 minutes
Breath hydrogen response
At 240 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation.
Measured: 240 minutes
Secondary outcomes (1)
Gastrointestinal tolerance
Subjects will answer a 7 symptom questionnaire regarding the intensity of gastrointestinal symptoms experienced following consumption of each of the supplements. Questionnaire is adapted from the validated Bovenshen gastrointestinal tolerance questionnaire. Questionnaire is to be completed at baseline, 30 min, 60 min, 90 min, 120 min, 180 min, 12 hours, 24 and 48 hours.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667184
- Sponsor's protocol ID
- 1507E75043
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Erickson J, Korczak R, Wang Q, Slavin J. Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial. Nutr J. 2017 May 25;16(1):35. doi: 10.1186/s12937-017-0256-3.
PubMed 28545589
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Health Human Subjects
- ClinicalTrials.gov ID
- NCT02667184
- Acronym / sponsor ID
- 1507E75043
- Conditions
- Food Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over a 4 hour time period.
Detailed description
This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen and methane analysis at various time points over a 4 hour time period. Subjects will also be asked to rate gastrointestinal symptoms via a questionnaire at various time points throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP Oral Nutrition Supplement 1 | Experimental | Dietary Supplement: Low FODMAP Oral Nutrition SupplementLow FODMAP Oral Nutrition Supplement |
| Low FODMAP Oral Nutrition Supplement 2 | Experimental | Dietary Supplement: Low FODMAP Oral Nutrition SupplementLow FODMAP Oral Nutrition Supplement |
| Low FODMAP Oral Nutrition Supplement 3 | Experimental | Dietary Supplement: Low FODMAP Oral Nutrition SupplementLow FODMAP Oral Nutrition Supplement |
| FOS Supplement | Experimental | Dietary Supplement: Low FODMAP Oral Nutrition SupplementSupplement containing fructooligosaccharides |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18-65 years with a body mass index between 18-29 kg/m2.
- Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures.
Key exclusion criteria (8 listed)
- Use of enemas, proton pump inhibitors, or antibiotics within the past 3 months
- Smoker
- Not a regular breakfast eater
- Self-reported history of a past or current gastrointestinal disease
- High fiber eater (> or = to 3 servings of high fiber foods per day)
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 |
|---|---|---|
| Low FODMAP Oral Nutrition Supplement | Dietary supplement | FOS Supplement, Low FODMAP Oral Nutrition Supplement 1, Low FODMAP Oral Nutrition Supplement 2, Low FODMAP Oral Nutrition Supplement 3 |
Primary outcome
Breath hydrogen response
Time frame: baseline
At baseline, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon.
Breath hydrogen response
Time frame: 60 minutes
At 60 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation in the colon.
Breath hydrogen response
Time frame: 120 minutes
At 120 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation.
Breath hydrogen response
Time frame: 240 minutes
At 240 minutes, subjects will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron Breath Track Analyzer. This will be a marker of carbohydrate fermentation.
1 secondary outcome
Gastrointestinal tolerance
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 28545589Erickson J, Korczak R, Wang Q, Slavin J. Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial. Nutr J. 2017 May 25;16(1):35. doi: 10.1186/s12937-017-0256-3.
- Individual participant dataSharing planned: No
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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 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 Low FODMAP Oral Nutrition Supplement 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 2 inclusion and 8 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 31 Jan 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Breath hydrogen response (time frame: baseline). The study lists 4 primary outcomes in all. 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 NCT02667184, 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 31 Jan 2017.