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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 250 mL medium viscosity
250 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose
Dietary supplement: oat beta-glucan
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:
  • oat soluble fibre
Experimental: 600 mL low viscosity
600 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose
Dietary supplement: oat beta-glucan
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:
  • oat soluble fibre
Experimental: 250 mL high viscosity
250 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose
Dietary supplement: oat beta-glucan
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:
  • oat soluble fibre
Experimental: 600 mL medium viscosity
600 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose
Dietary supplement: oat beta-glucan
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:
  • oat soluble fibre
Placebo Comparator: 250mL control
250 mL beverage containing 50g glucose
Dietary supplement: Placebo
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
Dietary supplement: Placebo
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guelph Food Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Toronto

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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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