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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consumption of the control white bread product (32 grams, 14.4 grams of carbohydrate) | Active Comparator |
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| Consumption of brown rice cake 40 grams (31 grams of carbohydrate) | Experimental |
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| Consumption of wild rice brown rice blend cake 40 grams (31 grams of carbohydrate) | Experimental |
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| Consumption of the control white bread product (66 grams, 31 grams of carbohydrate) | Active Comparator | This arm was conducted after the first three arms in a non-randomized add on session as we identified an issue with the amount of carbohydrate in out comparator being half of what it was supposed to be. This arm provided 66 grams of white bread control product and there will be a minimum of three days separating each visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White bread (control, 32 grams, 14.4 grams of carbohydrate) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of different wild rice products compared to products currently on the market on glycaemic control. | Finger stick blood glucose will be measured throughout each session. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the palatability of the wild rice products following consumption. | Visual Analogue Scale (VAS). | VAS measuring palatability will be completed immediately after the consumption of the treatments. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dylan MacKay, PHD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chronic Disease Innovation Centre, Seven Oaks Hospital | Winnipeg | Manitoba | R2V 3M3 | Canada |
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This is Trial 1 of a project that will consist of 2 acute double-blind cross-over trials. The trials will follow the same study design but investigate 2 types of wild rice products. The wild rice products will be provided by the Myera group.
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The allocation of this intervention order will be blinded for the investigators and the participants. Treatment will be given blinded names, such as A and B, but it may be possible to determine what each treatment is due to its appearance, however we will not be informing the participants what the treatments are. The study staff who will be preparing and overseeing the treatments may not be blinded due to the different appearances of the treatments. However, the staff that will conduct the trial results analyses will not be un-blinded until the analyses are complete.
| Brown rice cake | Other | A 40g rice cake made of 100% brown rice (providing 31 grams of carbohydrate) |
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| Wild rice (25%) and brown rice (75%) cake | Other | A 40g rice cake made of a blend of 25% wild rice and 75% brown rice (providing 31 grams of carbohydrate) |
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| White bread (control, 66 grams, 31 grams of carbohydrate) | Other | 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. |
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