Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497972
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-04
Brief Title:
Blood Glucose Response of Novel Wild Rice Enhanced Food Products Trial 1
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products ABWE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABWE
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 answer are
1 What is the effect compared to products currently on the market on glycaemic control
2 Is the wild rice product palatable
Participants will
consent to attend 4 study visits being 25 hours each
come to each visit fasted for at least 10-12 hours
complete a Motivation to Eat VAS following each blood measure
1 What is the effect compared to products currently on the market on glycaemic control
2 Is the wild rice product palatable
Participants will
consent to attend 4 study visits being 25 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 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 assessing a wild rice cake and a brown rice cake against a control of white bread
Participants will fast and arrive at the RCFTR between 700 and 1100 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 a wild rice cake 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
Participants will fast and arrive at the RCFTR between 700 and 1100 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 a wild rice cake 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None