The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form

Type 2 Diabetes Clinical Trial

Official title:

The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610518
• Other study ID #: UT25964
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: June 1, 2012
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: June 2012
• Source: Guelph Food Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	GILabs	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Guelph Food Research Centre	University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 h	No