Blood GlucoseEFGWNCT05976633
Glycemic Response to Wild Rice and Wild Rice Blends in Humans Study
A study testing Whole brown rice, Whole wild rice and 15% Wild rice and 85% Brown rice blend - Stovetop in people with Blood Glucose, run by University of Manitoba at 1 site in Canada.
Trial summary
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 that influence glycemic response to wild rice in healthy individuals. The main questions aim to answer: 1. 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?
- Whole brown rice, Whole wild rice and 15% Wild rice and 85% Brown rice blend - Stovetop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2023to 29 Feb 2024
- 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
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- Existing restrictive dietary habits (such a vegan, low carbohydrate/keto)
- 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
Richardson Center for Food Technology and Research
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Evaluating the Factors That Influence Glycemic Response to Wild Rice and Wild Rice Blends in Humans (EFGW) Study.
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 that influence glycemic response to wild rice in healthy individuals. The main questions aim to answer:
- Is there an effect of wild rice on blends on glycemic control and response?
- Does cooking wild rice via stovetop or microwave change its glycemic response?
- Is the wild rice blend product palatable?
- What is the subjective appetite when consuming the treatment?
Read more
Participants will:
- consent to attend 5 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
This study will be a crossover randomized trial consisting of 5 sessions. The wild rice products will be provided by the Myera group.
Participants will fast and arrive at the Richardson Centre for Food Technology and Research (RCFTR) between 7am - 11am on the session day. They will be provided either of the study treatments 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. VAS will be completed following consumption of the treatments to measure palatability and subjective appetite at baseline (0 min), and at 15, 30, 45, 60, 90, and 120 minute time points.
The primary objective is to test the effects of wild rice and wild rice blends compared to other rice on glycemic control and 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. Secondly, to test whether wild rice glycemic response is affected based on cooking method.
- Conditions
- Blood Glucose
- Being tested
- Whole white rice (control), Whole brown rice, Whole wild rice, 15% Wild rice and 85% Brown rice blend - Stovetop, 15% Wild rice and 85% Brown rice blend - Microwaved
- Keywords
- glycemic response, glycemic control, rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole white rice (control)Other
One serving size (140g cooked on stovetop) of whole white rice will be provided. Cooking time will be consistently maintained throughout.
Whole brown riceOther
One serving size (140g cooked on stovetop) of whole brown rice will be provided. Cooking time will be consistently maintained throughout.
Whole wild riceOther
One serving size (140g cooked on stovetop) of whole wild rice will be provided. Cooking time will be consistently maintained throughout.
15% Wild rice and 85% Brown rice blend - StovetopOther
One serving size (140g cooked on stovetop) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.
15% Wild rice and 85% Brown rice blend - MicrowavedOther
One serving size (140g cooked in microwave) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.
| Study group | Role | What they receive |
|---|---|---|
| Consumption of 1 of 3 rice products | Experimental | This arm will provide 1 of the 3 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit. Receives: Other: 15% Wild rice and 85% Brown rice blend - Stovetop |
| Consumption of 2 of 3 rice products | Experimental | This arm will provide the consumption of the second randomly assigned rice product. There will be a minimum of three days separating each visit. Receives: Other: Whole wild rice |
| Consumption of 3 of 3 rice products | Experimental | This arm will provide the third consumption of the randomly assigned rice product. There will be a minimum of three days separating each visit. Receives: Other: Whole brown rice |
| Consumption of the control rice product | Active comparator | This arm will provide the white rice control product. Receives: Other: Whole white rice (control) |
| Consumption of 1 of 3 rice products with different preparation method | Experimental | This arm will provide the blends product via a different cooking method (microwave). Receives: Other: 15% Wild rice and 85% Brown rice blend - Microwaved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic response
Finger stick blood glucose will be taken throughout each session.
Measured: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the treatment has been consumed..
Secondary outcomes (2)
Palatability of rice products
Visual Analogue Scale (VAS) assessment following consumption of the treatment
Measured: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes
Subjective appetite
Visual Analogue Scale (VAS) assessment following consumption of the treatment measurement.
Measured: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start14 Jul 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
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.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- crossover randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Sponsor
- Investigators
- Dylan MacKay, PHD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976633
- Sponsor's protocol ID
- HS25900 (B2023:033)
- Acronym
- EFGW
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Factors That Influence Glycemic Response to Wild Rice and Wild Rice Blends in Humans (EFGW) Study.
- ClinicalTrials.gov ID
- NCT05976633
- Acronym / sponsor ID
- EFGW / HS25900 (B2023:033)
- Conditions
- Blood Glucose
- Keywords
- glycemic response, glycemic control, rice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 4 Aug 2023 (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 clinical trial is to test the effects of wild rice and wild rice blends compared to other rice on glycemic control and evaluating factors that influence glycemic response to wild rice in healthy individuals. The main questions aim to answer:
- Is there an effect of wild rice on blends on glycemic control and response?
- Does cooking wild rice via stovetop or microwave change its glycemic response?
- Is the wild rice blend product palatable?
- What is the subjective appetite when consuming the treatment?
Participants will:
- consent to attend 5 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
This study will be a crossover randomized trial consisting of 5 sessions. The wild rice products will be provided by the Myera group.
Participants will fast and arrive at the Richardson Centre for Food Technology and Research (RCFTR) between 7am - 11am on the session day. They will be provided either of the study treatments 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. VAS will be completed following consumption of the treatments to measure palatability and subjective appetite at baseline (0 min), and at 15, 30, 45, 60, 90, and 120 minute time points.
The primary objective is to test the effects of wild rice and wild rice blends compared to other rice on glycemic control and 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. Secondly, to test whether wild rice glycemic response is affected based on cooking method.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- crossover randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Consumption of 1 of 3 rice products | Experimental | Other: 15% Wild rice and 85% Brown rice blend - StovetopThis arm will provide 1 of the 3 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit. |
| Consumption of 2 of 3 rice products | Experimental | Other: Whole wild riceThis arm will provide the consumption of the second randomly assigned rice product. There will be a minimum of three days separating each visit. |
| Consumption of 3 of 3 rice products | Experimental | Other: Whole brown riceThis arm will provide the third consumption of the randomly assigned rice product. There will be a minimum of three days separating each visit. |
| Consumption of the control rice product | Active comparator | Other: Whole white rice (control)This arm will provide the white rice control product. |
| Consumption of 1 of 3 rice products with different preparation method | Experimental | Other: 15% Wild rice and 85% Brown rice blend - MicrowavedThis arm will provide the blends product via a different cooking method (microwave). |
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 |
|---|---|---|
| Whole white rice (control)One serving size (140g cooked on stovetop) of whole white rice will be provided. Cooking time will be consistently maintained throughout. | Other | Consumption of the control rice product |
| Whole brown riceOne serving size (140g cooked on stovetop) of whole brown rice will be provided. Cooking time will be consistently maintained throughout. | Other | Consumption of 3 of 3 rice products |
| Whole wild riceOne serving size (140g cooked on stovetop) of whole wild rice will be provided. Cooking time will be consistently maintained throughout. | Other | Consumption of 2 of 3 rice products |
| 15% Wild rice and 85% Brown rice blend - StovetopOne serving size (140g cooked on stovetop) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout. | Other | Consumption of 1 of 3 rice products |
| 15% Wild rice and 85% Brown rice blend - MicrowavedOne serving size (140g cooked in microwave) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout. | Other | Consumption of 1 of 3 rice products with different preparation method |
Primary outcome
Glycemic response
Time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the treatment has been consumed..
Finger stick blood glucose will be taken throughout each session.
2 secondary outcomes
Palatability of rice products
Time frame: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes
Subjective appetite
Time frame: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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 Whole brown rice, Whole wild rice and 15% Wild rice and 85% Brown rice blend - Stovetop in people with Blood Glucose, run by University of Manitoba 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glycemic response (time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the treatment has been consumed..). 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 15 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.