Glucose IntoleranceNCT02801916
Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
A study testing 0 grams oat bran, 4.5 grams oat bran and 13.6 grams oat bran in people with Glucose Intolerance, run by Glycemic Index Laboratories, Inc.
Trial summary
Viscous dietary fibers including oat β-glucan are one of the most effective classes of functional food ingredients for reducing postprandial blood glucose. The mechanism of action is thought to be via an increase in viscosity of the stomach contents that delays gastric emptying and reduces mixing of food with… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- 0 grams oat bran, 4.5 grams oat bran and 13.6 grams oat bran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2015
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
Who cannot join
- Pregnancy
- Diabetes
- Recent medical or surgical hospitalization
- Use of drugs influencing glucose metabolism
- Use of drugs influencing gastrointestinal function
- Allergy to oats or wheat
About this study
Viscous dietary fibers including oat β-glucan are one of the most effective classes of functional food ingredients for reducing postprandial blood glucose. The mechanism of action is thought to be via an increase in viscosity of the stomach contents that delays gastric emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose absorption. Previous studies suggest that taking viscous fibers separate from a meal may not be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g) containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal of white bread on glycemic responses in 10 healthy humans.
- Conditions
- Glucose Intolerance
- Being tested
- 0 grams oat bran, 4.5 grams oat bran, 13.6 grams oat bran, 27.3 grams oat bran
- Keywords
- Humans, Glycemic response, Oat beta-glucan
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 grams oat branOther
200 milliliters water plus 0 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
4.5 grams oat branOther
200 milliliters water plus 4.5 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
13.6 grams oat branOther
200 milliliters water plus 13.6 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
27.3 grams oat branOther
200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
| Study group | Role | What they receive |
|---|---|---|
| Study subjects | Other | Each healthy subject will receive each of the interventions in randomized order. Receives: Other: 0 grams oat bran; Other: 4.5 grams oat bran; Other: 13.6 grams oat bran; Other: 27.3 grams oat bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose AUC
Incremental area under the blood glucose response curve from 0 hours (fasting) to 2 hours after eating ignoring area below fasting
Measured: 0 to 2 hours after test meal
Secondary outcomes (1)
Peak rise of blood glucose
Highest concentration of blood glucose within 2 hours of eating minus the fasting glucose concentration
Measured: 0 to 2 hours after test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycemic Index Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801916
- Sponsor's protocol ID
- GIL1527b
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
- ClinicalTrials.gov ID
- NCT02801916
- Acronym / sponsor ID
- GIL1527b
- Conditions
- Glucose Intolerance
- Keywords
- Humans, Glycemic response, Oat beta-glucan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Glycemic Index Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Jun 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.
Viscous dietary fibers including oat β-glucan are one of the most effective classes of functional food ingredients for reducing postprandial blood glucose. The mechanism of action is thought to be via an increase in viscosity of the stomach contents that delays gastric emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose absorption. Previous studies suggest that taking viscous fibers separate from a meal may not be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g) containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal of white bread on glycemic responses in 10 healthy humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study subjects | Other | Other: 0 grams oat bran, Other: 4.5 grams oat bran, Other: 13.6 grams oat bran, Other: 27.3 grams oat branEach healthy subject will receive each of the interventions in randomized order. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects
Key exclusion criteria (6 listed)
- Pregnancy
- Diabetes
- Recent medical or surgical hospitalization
- Use of drugs influencing glucose metabolism
- Use of drugs influencing gastrointestinal function
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 |
|---|---|---|
| 0 grams oat bran200 milliliters water plus 0 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread | Other | Study subjects |
| 4.5 grams oat bran200 milliliters water plus 4.5 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread | Other | Study subjects |
| 13.6 grams oat bran200 milliliters water plus 13.6 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread | Other | Study subjects |
| 27.3 grams oat bran200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread | Other | Study subjects |
Primary outcome
Glucose AUC
Time frame: 0 to 2 hours after test meal
Incremental area under the blood glucose response curve from 0 hours (fasting) to 2 hours after eating ignoring area below fasting
1 secondary outcome
Peak rise of blood glucose
Time frame: 0 to 2 hours after test meal
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 16 Jun 2016.
- 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.
Thomas MS Wolever, MD, PhD principal investigator
Glycemic Index Laboratories, Inc
Questions about this trial
What is this clinical trial studying?
A study testing 0 grams oat bran, 4.5 grams oat bran and 13.6 grams oat bran in people with Glucose Intolerance, run by Glycemic Index Laboratories, Inc.
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 1 inclusion and 6 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Glucose AUC (time frame: 0 to 2 hours after test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2016.