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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new wild rice cake affects blood sugar levels compared to common products like white bread. Researchers aim to determine if this wild rice product can help control blood sugar and whether participants find it tasty. Participants will try different food products over several visits, arriving with an empty stomach each time. This trial may suit those who typically eat breakfast, have stable blood sugar levels, and are willing to avoid certain medications that affect carbohydrates. As an unphased trial, it offers a unique opportunity to contribute to nutritional science and explore new dietary options.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking medications or supplements that affect carbohydrate metabolism, like 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 wild rice products are generally safe for consumption. Studies have found that adding 25% wild rice to brown rice cakes does not significantly affect blood sugar levels, indicating safety in this aspect.

In another study, researchers are examining whether wild rice products cause any unpleasant side effects. So far, no serious issues have been reported. As this is an early trial, the main goal is to ensure safety and determine the appropriate dosage. If wild rice is already approved for other uses, it provides additional confidence in its safety. However, researchers continue to study specific side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about wild rice enhanced food products for blood sugar control because they offer a natural and dietary approach to managing glucose levels, unlike traditional treatments such as oral medications and insulin injections. Wild rice is unique because it combines a low glycemic index with high fiber content, which can help stabilize blood sugar levels more effectively than refined grains. Additionally, incorporating wild rice into food products provides a new method of delivery that is both convenient and holistic, potentially offering health benefits beyond just blood sugar control.

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 other foods. Studies have found that eating wild rice can improve insulin use, thereby lowering blood sugar. Previous research suggests that replacing brown rice with wild rice can reduce blood sugar and insulin spikes, particularly in overweight individuals. This trial will test the effectiveness of wild rice products in managing blood sugar levels. Participants will consume either a wild rice and brown rice blend cake or a brown rice cake, while others will consume a control white bread product. These findings suggest that wild rice products could effectively manage blood sugar levels. ^{1 2 4 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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Consumption of wild rice brown rice blend cake 40 grams (31 grams of carbohydrate) Experimental Treatment 1 Intervention

Group II: Consumption of brown rice cake 40 grams (31 grams of carbohydrate) Experimental Treatment 1 Intervention

Group III: Consumption of the control white bread product (66 grams, 31 grams of carbohydrate) Active Control 1 Intervention

This arm was conducted after the first three arms in a non-randomized add on session as we identified an issue with the amount of carbohydrate in out comparator being half of what it was supposed to be. This arm provided 66 grams of white bread control product and there will be a minimum of three days separating each visit.

Group IV: Consumption of the control white bread product (32 grams, 14.4 grams of carbohydrate) Active Control 1 Intervention

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+

Citations

1. 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 ...

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/NCT06498024

Blood Glucose Response of Novel Wild Rice Enhanced ... The primary objective is to test the effects of different wild rice products compared to products currently on the market by evaluating factors that influence ...

4. withpower.com withpower.com/trial/phase-glucose-blood-6-2024-d8ac0

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

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

investigating the postprandial glycemic response to wild rice Outcomes. Substituting brown rice (BR) for wild rice (WR) consumption may aid in lowering blood glucose and insulin reactions in overweight individuals. Brown ...

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 is the first of the two trials and will be assessing a wild rice cake and a brown rice cake against a control of white bread.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11044462/

Effects of whole grains on glycemic control: a systematic ... Our study findings suggest that a daily intake of more than 150 g of whole grain ingredients is recommended as a population approach for diabetes prevention.