Wild Rice Cereal 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: 6

Duration: 6 visits over approximately 3 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking medications or supplements that may affect carbohydrate metabolism, such as adrenergic blockers, diuretics, thiazolidinediones, metformin, and systemic corticosteroids, at least 4 weeks before the screening visit.

What data supports the effectiveness of the treatment Wild Rice Cereal for Blood Sugar Control?

Research shows that wild rice has a low glycemic index (a measure of how quickly foods raise blood sugar levels) and can improve insulin resistance (when the body doesn't respond well to insulin) in rats. Additionally, other types of rice, like high resistant starch rice, have been shown to improve blood sugar levels in people with type 2 diabetes. ^{1 2 3 4 5}

Is wild rice cereal safe for human consumption?

The research does not provide specific safety data for wild rice cereal in humans, but studies on similar rice products suggest they are generally safe and may help with blood sugar control. ^{3 4 6 7 8}

How is the Wild Rice Cereal treatment different from other treatments for blood sugar control?

The Wild Rice Cereal treatment is unique because it uses wild rice, which has a lower glycemic index (a measure of how quickly foods raise blood sugar levels) compared to regular rice, potentially making it more suitable for managing blood sugar levels. Additionally, wild rice may help improve insulin resistance (when the body's cells don't respond well to insulin) in a way that other rice-based treatments do not. ^{1 4 9 10 11}

What is the purpose of this trial?

The goal of this acute double-blind cross over trial to test the effects of different wild rice cereal products 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 6 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 wild rice cereal products affect blood sugar levels. Participants must be willing to attend six study visits, each lasting 2.5 hours, and come fasted for at least 10-12 hours prior to each visit.

Inclusion Criteria

BMI range in between 18.9-29.9 kg/m2

Fasting glucose <5.6 mmol/L

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

Exclusion Criteria

I can complete study treatments in less than 10 minutes.

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

Recent history (within 12 month of screening) or current consumption of >14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants attend 6 study visits to test the effects of different wild rice cereal products on glycaemic control

6 visits over approximately 3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Novel Wild Rice Enhanced Food Products

Trial Overview The trial is testing the blood glucose response to various cereals including a novel cereal made from Canadian wild rice and fava beans, with variations including purple powder from sweet potatoes, compared to a control of Kellogg's Rice Krispies.

Participant Groups

Group I: Third consumption of 1 of 4 rice products Experimental Treatment 1 Intervention

This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.

Group II: Second consumption of 1 of 4 rice products Experimental Treatment 1 Intervention

This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.

Group III: Final consumption of 1 of 4 rice products Experimental Treatment 1 Intervention

This arm will provide 1 of the 4 randomly assigned rice products to the participant.

Group IV: Consumption of 1 of 4 rice products Experimental Treatment 1 Intervention

This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.

Group V: Final consumption of 1 of 2 control rice cereal products Active Control 1 Intervention

This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit.

Group VI: Consumption of 1 of 2 control rice cereal products Active Control 1 Intervention

This arm will provide one of the 2 white rice control products 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+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Protein Industries Canada

Collaborator

Trials

2

Recruited

40+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a novel rice-based diabetes-specific formula on postprandial glucose and gastrointestinal hormones: a double-blinded multi-arm randomized crossover trial. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Effects of brown rice on metabolomics related to glucose and lipid in normal rats]. [2021]

3. China pubmed.ncbi.nlm.nih.gov

Eating glutinous brown rice for one day improves glycemic control in Japanese patients with type 2 diabetes assessed by continuous glucose monitoring. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Determination of the glycemic index of the wild rice and the effects of wild rice on insulin resistance in rats]. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Naturally cultured high resistant starch rice improved postprandial glucose levels in patients with type 2 diabetes: A randomized, double-blinded, controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Whole Grain Brown Rice Extrudate Ameliorates the Symptoms of Diabetes by Activating the IRS1/PI3K/AKT Insulin Pathway in db/db Mice. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Effects of single ingestion of rice cracker and cooked rice with high resistant starch on postprandial glucose and insulin responses in healthy adults: two randomized, single-blind, cross-over trials. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Improvement in the metabolic markers of prediabetic subjects due to the partial substitution of Taiken9 rice by RD43 rice in their daily diet: a randomized clinical trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Glycemic response of rice, wheat and finger millet based diabetic food formulations in normoglycemic subjects. [2017]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Glucomannan Inhibits Rice Gruel-Induced Increases in Plasma Glucose and Insulin Levels. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Whole grain rice: Updated understanding of starch digestibility and the regulation of glucose and lipid metabolism. [2022]