Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, R2V 3M3, Canada
NCT Number: NCT06497972
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 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
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R2V 3M3, Canada
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 7:00 and 11:00 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
32 grams of white bread, providing 14.4 grams of carbohydrate, which was incorrectly dosed and matched only half the carbohydrate in the rice cakes.
A 40g rice cake made of 100% brown rice (providing 31 grams of carbohydrate)
A 40g rice cake made of a blend of 25% wild rice and 75% brown rice (providing 31 grams of carbohydrate)
66 grams of white bread, providing 31 grams of carbohydrate, this arm was added after the mistake in the first control dosing was discovered, so this arm was not randomized and was completed after the first three.
Time frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the first bite of treatment.
Finger stick blood glucose will be measured throughout each session.
Time frame: VAS measuring palatability will be completed immediately after the consumption of the treatments.
Visual Analogue Scale (VAS).
Dylan MacKay
Other
Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products (ABWE) Study
Acronym: ABWE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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