Blood GlucoseABWENCT06498024
Blood Glucose Response of Novel Wild Rice Enhanced Food Products (Trial 2)
A study testing Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk, Novel cereal (40% Canadian wild rice, 60% fava bean blend) and Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) in people with Blood Glucose, run by Dylan MacKay at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk, Novel cereal (40% Canadian wild rice, 60% fava bean blend) and Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial
- Male or female between 18-50 years old
- BMI range in between 18.9-29.9 kg/m2
- Fasting glucose <5.6 mmol/L
- Usually eat breakfast
- Participant must receive at least two doses of COVID-19 vaccine that have been recognized by Winnipeg Regional Health Authorities.
- In the Investigator's opinion is able and willing to comply with all trial requirements
Who cannot join
- Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Participants who indicate that they could not finish study treatments within 10 minutes
- Use of medication or supplements that may influence carbohydrate metabolism, including, not limit to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
- History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
- Intolerance or allergic reaction to rice
Show all 13Show fewer
- Existing restrictive dietary habits (such a vegan, low carbohydrate/keto) Date and version No: December 12 , 2022, Version 2 Page 7 of 15
- History of hypertension
- History of cancer within the last two years (except for non-melanoma skin cancer)
- 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
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks
- Had significant physical trauma or major surgery in the past 3 month or had trauma or major surgery in the past 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products (ABWE) Study
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:
- What is the effect compared to products currently on the market on glycaemic control?
- 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
Read the detailed description
The study will consist of 2 acute double-blind cross-over trials and both trials investigate types of wild rice products tested against a white rice or white bread control. This is the second of the two trials and will be assessing four wild rice cereals against two control rice cereals.
Participants will fast and arrive at the RCFTR between 8 and 10:30 am on the session day. They will be provided either of the study treatment based on randomization sequence. Baseline blood glucose (0 min) will be measured twice via finger stick blood sample right before their first bite of the study product, and at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. The timer will be started when they take their first bite. VAS will be completed following consumption of the treatments to measure palatability.
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 glycemic response to wild rice in humans, performed via the finger stick blood glucose that will be measured throughout each session as outlined above.
- Conditions
- Blood Glucose
- Being tested
- Kellogg's - rice krispies (control), Kellogg's - rice krispies (control) + 125ml milk, Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk, Novel cereal (40% Canadian wild rice, 60% fava bean blend), Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)
- Keywords
- glycemic response, glycemic control, rice, cereal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kellogg's - rice krispies (control)Other
One serving size (140g) of whole white rice cereal will be provided. Preparation will be consistently maintained throughout.
Kellogg's - rice krispies (control) + 125ml milkOther
One serving size (140g) of whole white rice cereal with 125ml of milk will be provided. Preparation will be consistently maintained throughout.
Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milkOther
One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with 125ml of milk will be provided. Preparation will be consistently maintained throughout.
Novel cereal (40% Canadian wild rice, 60% fava bean blend)Other
One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) will be provided. Preparation will be consistently maintained throughout.
Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)Other
One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with a 10% added purple powder (sweet potato) will be provided. Preparation will be consistently maintained throughout.
Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milkOther
One serving size (140g) of novel cereal (40% Canadian wild rice, 50% fava bean blend) and 10% purple powder (sweet potato) with 125 ml milk. Preparation will be consistently maintained throughout.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of 1 of 2 control rice cereal products | Active comparator | This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit. Receives: Other: Kellogg's - rice krispies (control) |
| Final consumption of 1 of 2 control rice cereal products | Active comparator | This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit. Receives: Other: Kellogg's - rice krispies (control) + 125ml milk |
| Consumption of 1 of 4 rice products | Experimental | 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. Receives: Other: Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk |
| Second consumption of 1 of 4 rice products | Experimental | 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. Receives: Other: Novel cereal (40% Canadian wild rice, 60% fava bean blend) |
| Third consumption of 1 of 4 rice products | Experimental | 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. Receives: Other: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) |
| Final consumption of 1 of 4 rice products | Experimental | This arm will provide 1 of the 4 randomly assigned rice products to the participant. Receives: Other: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of different wild rice products compared to products currently on the market on glycaemic control.
Finger stick blood glucose will be measured throughout each session.
Measured: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.
Secondary outcomes (1)
To measure the palatability of the wild rice products following consumption.
Visual Analogue Scale (VAS).
Measured: VAS measuring palatability will be completed right after the consumption of the treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Sep 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: The wild rice cereal development was stopped, so the trial was also withdrawn prior to starting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The project will consist of 2 acute double-blind cross-over trials. The trials will follow the same study design but investigate 2 types of wild rice products. The wild rice products will be provided by the Myera group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dylan MacKay
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Sponsor-investigator, Dylan MacKay, University of Manitoba
- Investigators
- Dylan MacKay, PHD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498024
- Sponsor's protocol ID
- HS25756 (B2022:104) (Trial 2)
- Acronym
- ABWE
- Status last verified
- Aug 2025
- First submitted
- 4 Jul 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products (ABWE) Study
- ClinicalTrials.gov ID
- NCT06498024
- Acronym / sponsor ID
- ABWE / HS25756 (B2022:104) (Trial 2)
- Conditions
- Blood Glucose
- Keywords
- glycemic response, glycemic control, rice, cereal
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The wild rice cereal development was stopped, so the trial was also withdrawn prior to starting.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dylan MacKayUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the effect compared to products currently on the market on glycaemic control?
- 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
Detailed description
The study will consist of 2 acute double-blind cross-over trials and both trials investigate types of wild rice products tested against a white rice or white bread control. This is the second of the two trials and will be assessing four wild rice cereals against two control rice cereals.
Participants will fast and arrive at the RCFTR between 8 and 10:30 am on the session day. They will be provided either of the study treatment based on randomization sequence. Baseline blood glucose (0 min) will be measured twice via finger stick blood sample right before their first bite of the study product, and at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. The timer will be started when they take their first bite. VAS will be completed following consumption of the treatments to measure palatability.
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 glycemic response to wild rice in humans, performed via the finger stick blood glucose that will be measured throughout each session as outlined above.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- The project will consist of 2 acute double-blind cross-over trials. The trials will follow the same study design but investigate 2 types of wild rice products. The wild rice products will be provided by the Myera group.
| Arm | Type | Receives |
|---|---|---|
| Consumption of 1 of 2 control rice cereal products | Active comparator | Other: Kellogg's - rice krispies (control)This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit. |
| Final consumption of 1 of 2 control rice cereal products | Active comparator | Other: Kellogg's - rice krispies (control) + 125ml milkThis arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit. |
| Consumption of 1 of 4 rice products | Experimental | Other: Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milkThis 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. |
| Second consumption of 1 of 4 rice products | Experimental | Other: Novel cereal (40% Canadian wild rice, 60% fava bean blend)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. |
| Third consumption of 1 of 4 rice products | Experimental | Other: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)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. |
| Final consumption of 1 of 4 rice products | Experimental | Other: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milkThis arm will provide 1 of the 4 randomly assigned rice products to the participant. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or female between 18-50 years old
- BMI range in between 18.9-29.9 kg/m2
- Fasting glucose <5.6 mmol/L
- Usually eat breakfast
Key exclusion criteria (13 listed)
- Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Participants who indicate that they could not finish study treatments within 10 minutes
- Use of medication or supplements that may influence carbohydrate metabolism, including, not limit to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
- History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kellogg's - rice krispies (control)One serving size (140g) of whole white rice cereal will be provided. Preparation will be consistently maintained throughout. | Other | Consumption of 1 of 2 control rice cereal products |
| Kellogg's - rice krispies (control) + 125ml milkOne serving size (140g) of whole white rice cereal with 125ml of milk will be provided. Preparation will be consistently maintained throughout. | Other | Final consumption of 1 of 2 control rice cereal products |
| Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milkOne serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with 125ml of milk will be provided. Preparation will be consistently maintained throughout. | Other | Consumption of 1 of 4 rice products |
| Novel cereal (40% Canadian wild rice, 60% fava bean blend)One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) will be provided. Preparation will be consistently maintained throughout. | Other | Second consumption of 1 of 4 rice products |
| Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with a 10% added purple powder (sweet potato) will be provided. Preparation will be consistently maintained throughout. | Other | Third consumption of 1 of 4 rice products |
| Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milkOne serving size (140g) of novel cereal (40% Canadian wild rice, 50% fava bean blend) and 10% purple powder (sweet potato) with 125 ml milk. Preparation will be consistently maintained throughout. | Other | Final consumption of 1 of 4 rice products |
Primary outcome
The effects of different wild rice products compared to products currently on the market on glycaemic control.
Time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.
Finger stick blood glucose will be measured throughout each session.
1 secondary outcome
To measure the palatability of the wild rice products following consumption.
Time frame: VAS measuring palatability will be completed right after the consumption of the treatments.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan MacKay, PHD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk, Novel cereal (40% Canadian wild rice, 60% fava bean blend) and Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) in people with Blood Glucose, run by Dylan MacKay at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of different wild rice products compared to products currently on the market on glycaemic control. (time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.