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| ID | Type | Description | Link |
|---|---|---|---|
| 200603 | Other Grant/Funding Number | OMAFRA |
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| Name | Class |
|---|---|
| Ontario Ministry of Agriculture, Food and Rural Affairs | OTHER_GOV |
| Natural Sciences and Engineering Research Council, Canada | OTHER |
| Dairy Farmers of Ontario | OTHER |
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The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.
The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product. To accomplish this, a randomized, double-blinded, placebo controlled, crossover study design will be used, in order to determine the different effects of a variety of fibre-enriched pudding products on markers of type 2 diabetes and satiety response, versus low-fibre control puddings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapioca Starch - Low-Fibre | Placebo Comparator | Tapoica starch pudding without added fibre |
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| High Maltose Corn Syrup - Low-Fibre | Placebo Comparator | High maltose corn syrup pudding without added fibre |
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| Trutol Glucose Beverage (#1) | Placebo Comparator | Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit. |
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| Trutol Glucose Beverage (#2) | Placebo Comparator | Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit. |
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| Yellow Mustard Gum Fibre - Tapioca Starch | Active Comparator | Yellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. |
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| Yellow Mustard Gum Fibre - High Maltose Corn Syrup |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yellow Mustard Gum Fibre | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Fasting and postprandial blood glucose response for each pudding and control product | Blood glucose will be measured in the fasting state and postprandially through finger prick blood samples at each study visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed. | Blood glucose will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products. |
| Fasting and postprandial insulin response for each pudding and control product | Insulin will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed. | Blood insulin will be analyzed for each each study visit (10 in total), at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products. |
| Fasting and postprandial acetaminophen absorption for each pudding and control product | Acetaminophen will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed. | Blood acetaminophen will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products. |
| Satiety-producing effect for each pudding and control product |
| Measure | Description | Time Frame |
|---|---|---|
| 3-Day food records | Participants will complete 3-day food records before the first treatment study visit to provide information about their background nutrient intake and dietary habits. | Over 3 days before the first treatment study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Fasted body weight | Fasted body weight will be measured at each study before consuming the treatment product. | At each study treatment visit |
| Heart rate and blood pressure | Heart rate (beats per minute) and blood pressure (systolic/diastolic mmHg) will be measured at each study treatment visit before consuming the treatment product. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison M Duncan, Ph.D., R.D. | University of Guelph, Human Nutraceutical Research Unit | Principal Investigator |
| Amanda J Wright, Ph.D. | University of Guelph, Human Nutraceutical Research Unit | Study Director |
| Alison M Duncan, Ph.D., R.D. | University of Guelph, Human Nutraceutical Research Unit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutraceutical Research Unit | Guelph | Ontario | N1G 2W1 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Agriculture and Agri-Food Canada |
| OTHER_GOV |
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| Active Comparator |
Yellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. |
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| Soluble Flaxseed Gum Fibre - Tapioca Starch | Active Comparator | Soluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. |
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| Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup | Active Comparator | Soluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. |
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| Fenugreek Gum Fibre - Tapioca Starch | Active Comparator | Fenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product. |
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| Fenugreek Gum Fibre - High Maltose Corn Syrup | Active Comparator | Fenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product. |
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| Soluble Flaxseed Gum Fibre | Other |
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| Fenugreek Gum Fibre | Other |
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Participants will complete visual analogue scale (VAS) questionnaires during each treatment visit to subjectively measure satiety. They will be asked to complete an initial VAS questionnaire when fasted, and will then consume one of 10 treatments within 10 minutes, and complete VAS questionnaires 5 minutes before each blood sample at times 10, 25, 55, 85, and 115 minutes. After 120 minutes have passed, participants will consume an ad libitum pizza lunch buffet meal to objectively measure satiety, and once comfortably full they will complete a final VAS questionnaire. Weighed food records will be used to objectively measure food intake for the rest of the day. This will occur once a week for 10 weeks until all treatments have been consumed. |
| Satiety will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products. |
| At each study treatment visit |
| D004700 | Endocrine System Diseases |