Type 2 DiabetesNCT01610518
The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form
A study testing oat beta-glucan in people with Type 2 Diabetes, run by Guelph Food Research Centre at 1 site in Canada.
Trial summary
The ability of oat β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. To our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when concentration, and thus viscosity, is varied by changing… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- oat beta-glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Apr 2011
- 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 men and women
Who cannot join
- BMI greater than or equal to 35
- known to have diabetes, HIV, hepatitis or a heart condition
- use of medications or having a condition which may harm the subjects
- use of medication which may affect the study results
Trial locations and contacts
1 site in 1 country.
About this study
The ability of oat β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. To our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when concentration, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. Therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre.
Read the detailed description
The ability of β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. It has been demonstrated that the viscosity of a β-glucan solution increases with the molecular weight (MW) of β-glucan polymers, as well as the dose or concentration (C) of those polymers in solution. Numerous studies have shown that glycemic response-lowering is strengthened when the C of a β-glucan solution of fixed liquid volume is increased by increasing β-glucan dose. However, the C of a β-glucan solution depends on not only the amount of fibre present but also on the solution volume. To our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when C, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. Therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre. Knowing how to incorporate β-glucan into solution so that its physiological benefits are preserved will assist in the development of β-glucan-containing functional foods.
- Conditions
- Type 2 Diabetes
- Being tested
- oat beta-glucan, Placebo
- Keywords
- postprandial blood glucose, dietary fiber, beta-glucan
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oat beta-glucanDietary supplement
Also called oat soluble fibre
4g dose for each arm of trial. Form (volume and viscosity) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms.
PlaceboDietary supplement
Control without beta-glucan. Form (volume) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms.
| Study group | Role | What they receive |
|---|---|---|
| 250 mL medium viscosity | Experimental | 250 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose Receives: Dietary Supplement: oat beta-glucan |
| 600 mL low viscosity | Experimental | 600 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose Receives: Dietary Supplement: oat beta-glucan |
| 250 mL high viscosity | Experimental | 250 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose Receives: Dietary Supplement: oat beta-glucan |
| 600 mL medium viscosity | Experimental | 600 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose Receives: Dietary Supplement: oat beta-glucan |
| 250mL control | Placebo comparator | 250 mL beverage containing 50g glucose Receives: Dietary Supplement: Placebo |
| 600mL control | Placebo comparator | 600mL beverage containing 50g glucose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial blood glucose
Two fasting blood samples spaced 5 minutes apart (-5 min and 0 min) were collected by finger-prick using a monoejector lancet device. Immediately following the collection of the second blood sample, subjects consumed a test solution and 250mL of a beverage of their choice (water, tea or coffee with milk and/ or artificial sweetener aspartame). Subjects received the same beverage and volume of that beverage for each test in the study. Additional finger-prick blood samples were taken at 10, 20, 30, 40, 50, 60, 90 and 120 minutes after the start of the meal.
Measured: 2 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guelph Food Research Centre
- Sponsor type
- Other government
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Dr. Susan M. Tosh, Guelph Food Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610518
- Sponsor's protocol ID
- UT25964
- Status last verified
- Jun 2012
- First submitted
- 31 May 2012
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolever TM, Jenkins DJ, Jenkins AL, Josse RG. The glycemic index: methodology and clinical implications. Am J Clin Nutr. 1991 Nov;54(5):846-54. doi: 10.1093/ajcn/54.5.846.
PubMed 1951155Wood PJ, Beer MU, Butler G. Evaluation of role of concentration and molecular weight of oat beta-glucan in determining effect of viscosity on plasma glucose and insulin following an oral glucose load. Br J Nutr. 2000 Jul;84(1):19-23.
PubMed 10961156
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form
- ClinicalTrials.gov ID
- NCT01610518
- Acronym / sponsor ID
- UT25964
- Conditions
- Type 2 Diabetes
- Keywords
- postprandial blood glucose, dietary fiber, beta-glucan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Guelph Food Research CentreOther government
- Collaborators
- University of Toronto
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jun 2012 (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 ability of oat β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. To our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when concentration, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. Therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre.
Detailed description
The ability of β-glucan to lower postprandial glycemic responses has been attributed to the viscosity of the solution in which the fibre is solubilized. It has been demonstrated that the viscosity of a β-glucan solution increases with the molecular weight (MW) of β-glucan polymers, as well as the dose or concentration (C) of those polymers in solution. Numerous studies have shown that glycemic response-lowering is strengthened when the C of a β-glucan solution of fixed liquid volume is increased by increasing β-glucan dose. However, the C of a β-glucan solution depends on not only the amount of fibre present but also on the solution volume. To our knowledge, no studies have investigated the effect of β-glucan solutions on glycemic response when C, and thus viscosity, is varied by changing the solution volume but not the β-glucan dose. Therefore, the investigators will test the effects of altering β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre. Knowing how to incorporate β-glucan into solution so that its physiological benefits are preserved will assist in the development of β-glucan-containing functional foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 250 mL medium viscosity | Experimental | Dietary Supplement: oat beta-glucan250 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose |
| 600 mL low viscosity | Experimental | Dietary Supplement: oat beta-glucan600 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose |
| 250 mL high viscosity | Experimental | Dietary Supplement: oat beta-glucan250 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose |
| 600 mL medium viscosity | Experimental | Dietary Supplement: oat beta-glucan600 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose |
| 250mL control | Placebo comparator | Dietary Supplement: Placebo250 mL beverage containing 50g glucose |
| 600mL control | Placebo comparator | Dietary Supplement: Placebo600mL beverage containing 50g glucose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy men and women
Key exclusion criteria (4 listed)
- BMI greater than or equal to 35
- known to have diabetes, HIV, hepatitis or a heart condition
- use of medications or having a condition which may harm the subjects
- use of medication which may affect the study results
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 |
|---|---|---|
| oat beta-glucanAlso: oat soluble fibre4g dose for each arm of trial. Form (volume and viscosity) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms. | Dietary supplement | 250 mL high viscosity, 250 mL medium viscosity, 600 mL low viscosity, 600 mL medium viscosity |
| PlaceboControl without beta-glucan. Form (volume) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms. | Dietary supplement | 250mL control, 600mL control |
Primary outcome
postprandial blood glucose
Time frame: 2 h
Two fasting blood samples spaced 5 minutes apart (-5 min and 0 min) were collected by finger-prick using a monoejector lancet device. Immediately following the collection of the second blood sample, subjects consumed a test solution and 250mL of a beverage of their choice (water, tea or coffee with milk and/ or artificial sweetener aspartame). Subjects received the same beverage and volume of that beverage for each test in the study. Additional finger-prick blood samples were taken at 10, 20, 30, 40, 50, 60, 90 and 120 minutes after the start of the 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 4 Jun 2012.
- Background: PubMed 1951155Wolever TM, Jenkins DJ, Jenkins AL, Josse RG. The glycemic index: methodology and clinical implications. Am J Clin Nutr. 1991 Nov;54(5):846-54. doi: 10.1093/ajcn/54.5.846.
- Background: PubMed 10961156Wood PJ, Beer MU, Butler G. Evaluation of role of concentration and molecular weight of oat beta-glucan in determining effect of viscosity on plasma glucose and insulin following an oral glucose load. Br J Nutr. 2000 Jul;84(1):19-23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oat beta-glucan in people with Type 2 Diabetes, run by Guelph Food Research Centre at 1 site in Canada.
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 4 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 Jun 2012. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
postprandial blood glucose (time frame: 2 h). 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 NCT01610518, which also lists 2 linked publications.
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 Jun 2012.