NCT01610518

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
Last Updated

June 4, 2012

Status Verified

June 1, 2012

Enrollment Period

28 days

First QC Date

May 31, 2012

Last Update Submit

June 1, 2012

Conditions

Type 2 Diabetes

Keywords

postprandial blood glucosedietary fiberbeta-glucan

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

250 mL medium viscosity

EXPERIMENTAL

250 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose

Dietary Supplement: oat beta-glucan

600 mL low viscosity

EXPERIMENTAL

600 mL beverage containing 4g low molecular weight oat beta-glucan and 50g glucose

Dietary Supplement: oat beta-glucan

250 mL high viscosity

EXPERIMENTAL

250 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose

Dietary Supplement: oat beta-glucan

600 mL medium viscosity

EXPERIMENTAL

600 mL beverage containing 4g high molecular weight oat beta-glucan and 50g glucose

Dietary Supplement: oat beta-glucan

250mL control

PLACEBO COMPARATOR

250 mL beverage containing 50g glucose

Dietary Supplement: Placebo

600mL control

PLACEBO COMPARATOR

600mL beverage containing 50g glucose

Dietary Supplement: Placebo

Interventions

oat beta-glucanDIETARY_SUPPLEMENT

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.

Also known as: oat soluble fibre
250 mL high viscosity250 mL medium viscosity600 mL low viscosity600 mL medium viscosity
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.

250mL control600mL control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men and women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GILabs

Toronto, Ontario, M5C 2N8, Canada

Location

Related 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. doi: 10.1093/ajcn/54.5.846.

    PMID: 1951155BACKGROUND

  • 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.

    PMID: 10961156BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

beta-glucan, (1-3)(1-4)-

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

February 1, 2011

Primary Completion

March 1, 2011

Study Completion

April 1, 2011

Last Updated

June 4, 2012

Record last verified: 2012-06

Locations

CA(1)