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

NCT ID: NCT02651597

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-12-10

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.

Conditions

Normoglycemic; Normal Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Low Viscous

Low Viscous Beta Glucan Oatmeal

Group Type: EXPERIMENTAL

Oatmeal

Intervention Type: OTHER

Medium Viscous

Medium Viscous Beta Glucan Oatmeal

Group Type: EXPERIMENTAL

Oatmeal

Intervention Type: OTHER

High Viscous

High Viscous Beta Glucan Oatmeal

Group Type: EXPERIMENTAL

Oatmeal

Intervention Type: OTHER

Interventions

Oatmeal

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2015:142

Identifier Type: -

Identifier Source: org_study_id