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The wild rice cereal development was stopped, so the trial was also withdrawn prior to starting.
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| Name | Class |
|---|---|
| Mitacs | INDUSTRY |
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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 aims to answer are:
Participants will:
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 two trials and will be assessing four wild rice cereals against two control rice cereals.
Participants will fast and arrive at the RCFTR between 8 and 10:30 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 different wild rice products 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 1 of 2 control rice cereal products | Active Comparator | This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit. |
|
| Final consumption of 1 of 2 control rice cereal products | Active Comparator | This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit. |
|
| Consumption of 1 of 4 rice products | Experimental | This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit. |
|
| Second consumption of 1 of 4 rice products | Experimental | This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit. |
|
| Third consumption of 1 of 4 rice products | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kellogg's - rice krispies (control) | Other | One serving size (140g) of whole white rice cereal will be provided. Preparation will be consistently maintained throughout. |
|
| 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 mins 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 right 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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The project 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.
This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.
|
| Final consumption of 1 of 4 rice products | Experimental | This arm will provide 1 of the 4 randomly assigned rice products to the participant. |
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| Kellogg's - rice krispies (control) + 125ml milk | Other | One serving size (140g) of whole white rice cereal with 125ml of milk will be provided. Preparation will be consistently maintained throughout. |
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| Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk | Other | One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with 125ml of milk will be provided. Preparation will be consistently maintained throughout. |
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| Novel cereal (40% Canadian wild rice, 60% fava bean blend) | Other | One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) will be provided. Preparation will be consistently maintained throughout. |
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| Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) | Other | One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with a 10% added purple powder (sweet potato) will be provided. Preparation will be consistently maintained throughout. |
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| Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milk | Other | One serving size (140g) of novel cereal (40% Canadian wild rice, 50% fava bean blend) and 10% purple powder (sweet potato) with 125 ml milk. Preparation will be consistently maintained throughout. |
|
| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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