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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new wild rice cereal products to determine if they control blood sugar better than regular cereals and if participants find them tasty. Participants will sample different rice products during several visits, spaced a few days apart. Ideal candidates regularly eat breakfast, have normal fasting blood sugar levels, and do not have rice allergies or specific health conditions. As an unphased trial, participants contribute to innovative research and may discover a new, tasty way to manage blood sugar.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rice products similar to the new wild rice food are generally safe and well-tolerated. Although specific safety data for wild rice cereal in humans is lacking, studies on related rice products have not identified major safety issues. This suggests that wild rice cereal should be safe to consume. However, it is important to consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the novel wild rice-enhanced food products because they offer a natural, dietary approach to blood sugar control, unlike standard medications like metformin or insulin injections. These products are derived from wild rice, which is rich in fiber and essential nutrients that may help regulate blood sugar levels more effectively. Additionally, using a food-based intervention could provide a more accessible and sustainable option for individuals looking to manage their blood sugar without the need for pharmaceuticals. This innovative approach highlights the potential of dietary modifications as a complementary strategy to current diabetes treatments.

What evidence suggests that this trial's treatments could be effective for blood sugar control?

Research shows that wild rice has a low glycemic index, meaning it raises blood sugar levels more slowly than some other foods. Studies indicate that eating wild rice can help with insulin resistance, a condition where the body struggles to use insulin properly. Insulin, a hormone, helps control blood sugar. Wild rice is also high in antioxidants and phenolic compounds, which are linked to better blood sugar control. Additionally, consuming whole grains like wild rice over time has been shown to lower fasting blood sugar levels compared to refined grains. This trial will test various wild rice cereal products to evaluate their effectiveness in managing blood sugar levels. ^{1 2 5 6 7}

Who Is on the Research Team?

Dylan MacKay, PHD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

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

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)

Body weight change over 3.5kg for the past 3 months

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06498024

Blood Glucose Response of Novel Wild Rice Enhanced ... 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 ...

2. withpower.com withpower.com/trial/phase-glucose-blood-8-2024-10467

Wild Rice Cereal for Blood Sugar Control (ABWE Trial) 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05976633

Study Details | NCT05976633 | Glycemic Response to Wild ... The goal of this clinical trial is to test the effects of wild rice and wild rice blends compared to other rice on glycemic control and evaluating factors ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9623515/

Effects of whole grain intake on glycemic control Medium‐/long‐term whole grain intake reduced the fasting glucose concentration compared with similar refined foods.

5. mspace.lib.umanitoba.ca mspace.lib.umanitoba.ca/bitstreams/c33d2095-9833-4ee0-9e52-ada691355ba1/download

investigating the postprandial glycemic response to wild rice Wild rice is rich in phenolic compounds and antioxidants, which are associated with improved glycemic control, reduced insulin resistance, and decreased ...

6. ctv.veeva.com ctv.veeva.com/study/blood-glucose-response-of-novel-wild-rice-enhanced-food-products-trial1

Blood Glucose Response of Novel Wild Rice Enhanced Food ... This trial will be an acute double-blind cross-over trial and will investigate 2 types of rice cake products tested against a white bread ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8467539/

Rice Compounds with Impact on Diabetes Control - PMC In this study, we reviewed the effects of rice glycemic index, macronutrients, and bioactive compounds on the pathological mechanisms associated with diabetes.