- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01610518
The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form
June 1, 2012 updated by: Dr. Susan M. Tosh, Guelph Food Research Centre
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2N8
- GILabs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy men and women
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 250 mL medium viscosity
250 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose
|
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.
Other Names:
|
|
Experimental: 600 mL low viscosity
600 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose
|
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.
Other Names:
|
|
Experimental: 250 mL high viscosity
250 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose
|
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.
Other Names:
|
|
Experimental: 600 mL medium viscosity
600 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose
|
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.
Other Names:
|
|
Placebo Comparator: 250mL control
250 mL beverage containing 50g glucose
|
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.
|
|
Placebo Comparator: 600mL control
600mL beverage containing 50g glucose
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Wood 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
May 31, 2012
First Submitted That Met QC Criteria
June 1, 2012
First Posted (Estimate)
June 4, 2012
Study Record Updates
Last Update Posted (Estimate)
June 4, 2012
Last Update Submitted That Met QC Criteria
June 1, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- UT25964
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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