Status:

COMPLETED

Blood Glucose Response of Novel Wild Rice Enhanced Food Products (Trial 1)

Lead Sponsor:

Dylan MacKay

Conditions:

Blood Glucose

Eligibility:

All Genders

18-50 years

Phase:

NA

Brief Summary

The goal of this acute double-blind cross over trial is to test the effects of a wild rice cake product compared to products currently on the market on glycaemic control. The main questions it aims to...

Detailed Description

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 control. This is the first of the two trials and will be asses...

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 :

July 5 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 18 2025

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT06497972

Start Date

July 5 2024

End Date

April 18 2025

Last Update

August 24 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, Canada, R2V 3M3