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A Study of the Effect of Oats on Post Prandial Glucose Response

Primary Purpose

Normoglycemic, Normal Body Weight

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oatmeal
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Normoglycemic focused on measuring Oatmeal, Beta glucan, Postprandial Glycemic Response, Blood Glucose

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Normoglycemic (<5.6 mmol/L)
  • BMI= 18.5-29.9 kg/m²

Exclusion Criteria:

  • A change in medication (dose or type) or medical event requiring hospitalization within the past month.
  • Daily tobacco use.
  • Eat meals at irregular or unusual times.
  • Food allergy, aversion or unwillingness to eat study foods.
  • Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar.
  • Presence of a gastrointestinal disorder.
  • Currently pregnant or lactating.

Sites / Locations

  • Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low Viscous

Medium Viscous

High Viscous

Arm Description

Low Viscous Beta Glucan Oatmeal

Medium Viscous Beta Glucan Oatmeal

High Viscous Beta Glucan Oatmeal

Outcomes

Primary Outcome Measures

Blood Glucose
Total area under the curve (iAUC, mmol*min/L) for glucose

Secondary Outcome Measures

Appetite (visual analogue scales)
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Physical Comfort
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Energy/Fatigue
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Palatability
Measured by VAS questionnaire at 12 time points used to calculate area under curve

Full Information

First Posted
January 6, 2016
Last Updated
January 19, 2023
Sponsor
University of Manitoba
Collaborators
PepsiCo Global R&D
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1. Study Identification

Unique Protocol Identification Number
NCT02651597
Brief Title
A Study of the Effect of Oats on Post Prandial Glucose Response
Official Title
A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 10, 2016 (Actual)
Study Completion Date
December 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
PepsiCo Global R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.
Detailed Description
The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited. Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit. Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS). Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters . Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week. During the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. The investigators will ask that participants go to sleep at the same time on the days before the sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normoglycemic, Normal Body Weight
Keywords
Oatmeal, Beta glucan, Postprandial Glycemic Response, Blood Glucose

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Viscous
Arm Type
Experimental
Arm Description
Low Viscous Beta Glucan Oatmeal
Arm Title
Medium Viscous
Arm Type
Experimental
Arm Description
Medium Viscous Beta Glucan Oatmeal
Arm Title
High Viscous
Arm Type
Experimental
Arm Description
High Viscous Beta Glucan Oatmeal
Intervention Type
Other
Intervention Name(s)
Oatmeal
Primary Outcome Measure Information:
Title
Blood Glucose
Description
Total area under the curve (iAUC, mmol*min/L) for glucose
Time Frame
0-200 mins
Secondary Outcome Measure Information:
Title
Appetite (visual analogue scales)
Description
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Time Frame
0-200 mins
Title
Physical Comfort
Description
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Time Frame
0-200 mins
Title
Energy/Fatigue
Description
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Time Frame
0-200mins
Title
Palatability
Description
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Time Frame
at 5 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normoglycemic (<5.6 mmol/L) BMI= 18.5-29.9 kg/m² Exclusion Criteria: A change in medication (dose or type) or medical event requiring hospitalization within the past month. Daily tobacco use. Eat meals at irregular or unusual times. Food allergy, aversion or unwillingness to eat study foods. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar. Presence of a gastrointestinal disorder. Currently pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Jones, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 6C5
Country
Canada

12. IPD Sharing Statement

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A Study of the Effect of Oats on Post Prandial Glucose Response

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