Wild Rice Products for Blood Sugar Control

(ABWE Trial)

Overseen By Dylan MacKay, PHD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dylan MacKay

Must not be taking: Adrenergic blockers, Diuretics

Disqualifiers: Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 visits over approximately 4 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this acute double-blind cross over trial is to test the effects of a wild rice cake product compared to products currently on the market on glycaemic control. The main questions it aims to answer are: 1. What is the effect compared to products currently on the market on glycaemic control? 2. Is the wild rice product palatable? Participants will: * consent to attend 4 study visits being 2.5 hours each * come to each visit fasted for at least 10-12 hours. * complete a Motivation to Eat VAS following each blood measure

Research Team

Dylan MacKay, PHD

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for individuals interested in how different rice products affect blood sugar levels. Participants must be willing to fast for 10-12 hours before each of the four study visits and complete a survey after each blood test. Specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I have received at least two COVID-19 vaccine doses approved by Winnipeg health authorities.

Usually eat breakfast

In the Investigator's opinion is able and willing to comply with all trial requirements

Exclusion Criteria

Existing restrictive dietary habits (such a vegan, low carbohydrate/keto)

I have a history of significant health issues, including eating disorders, AIDS, hepatitis, diabetes, heart disease, lung problems, or GI disorders.

I have not had major surgery or significant physical trauma in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants attend 4 study visits to test the effects of wild rice cake products on glycaemic control

4 visits over approximately 4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Wild Rice Enhanced Food Products

Trial Overview The trial is testing the impact on blood glucose control of three food products: white bread as a control, a cake made with wild rice (25%) and brown rice (75%), and a brown rice cake alone. It's designed to see if these foods differ from current market offerings in affecting blood sugar.

Participant Groups

Group I: Final consumption of 1 of 2 rice cake products Experimental Treatment 1 Intervention

This arm will provide 1 of the 2 randomly assigned rice products to the participant.

Group II: Consumption of 1 of 2 rice cake products Experimental Treatment 1 Intervention

This arm will provide 1 of the 2 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.

Group III: Consumption of the control white bread product Active Control 1 Intervention

This arm will provide the white bread control product and there will be a minimum of three days separating each visit.

Who Is Running the Clinical Trial?

Dylan MacKay

Lead Sponsor

Trials

3

Recruited

80+

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Protein Industries Canada

Collaborator

Trials

2

Recruited

40+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+