Status:
WITHDRAWN
Blood Glucose Response of Novel Wild Rice Enhanced Food Products (Trial 2)
Lead Sponsor:
Dylan MacKay
Collaborating Sponsors:
Mitacs
Conditions:
Blood Glucose
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06498024
Start Date
September 1 2025
End Date
September 1 2026
Last Update
August 24 2025
Active Locations (1)
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1
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, Canada, R2V 3M3