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

A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response

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.

Study Overview

• Status: Completed
• Conditions: Normal Body Weight; Normoglycemic
• Intervention / Treatment: Other: Oatmeal

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 6C5
      • Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Viscous; Low Viscous Beta Glucan Oatmeal	Other: Oatmeal
Experimental: Medium Viscous; Medium Viscous Beta Glucan Oatmeal	Other: Oatmeal
Experimental: High Viscous; High Viscous Beta Glucan Oatmeal	Other: Oatmeal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose	Total area under the curve (iAUC, mmol*min/L) for glucose	0-200 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite (visual analogue scales)	Measured by VAS questionnaire at 12 time points used to calculate area under curve	0-200 mins
Physical Comfort	Measured by VAS questionnaire at 12 time points used to calculate area under curve	0-200 mins
Energy/Fatigue	Measured by VAS questionnaire at 12 time points used to calculate area under curve	0-200mins
Palatability	Measured by VAS questionnaire at 12 time points used to calculate area under curve	at 5 mins

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: PepsiCo Global R&D
• Investigators: Principal Investigator: Peter Jones, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 10, 2016
• Study Completion (Actual): December 10, 2016

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Blood Glucose; Oatmeal; Beta glucan; Postprandial Glycemic Response
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: B2015:142