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| Name | Class |
|---|---|
| Ontario Ministry of Agriculture, Food and Rural Affairs | OTHER_GOV |
| Maple Leaf Foods, Canada Bread | UNKNOWN |
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The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.
Using a randomized, double-blind crossover study design, we will determine the effect of consuming bagels made with resistant starch daily for 8-weeks can reduce the risk of type 2 diabetes and colon cancer in an adults who are at an increased risk for type 2 diabetes. Additionally, we will compare the satiating effect of these bagels to that of a standard bagel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistant Starch Bagels | Active Comparator | Bagels made from high-resistant starch flour (provides 24g resistant starch per day) |
|
| Control Bagels | Placebo Comparator | Bagels made from wheat flour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistant Starch | Other | In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting and postprandial blood glucose | Blood glucose will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods. | up to day 57 of both treatment periods |
| Fasting and postprandial insulin | Circulating insulin will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods. | up to day 57 of both treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 1 and 57 of both treatment periods. | Day 1 and 57 of both treatment periods |
| Calculated insulin sensitivity and beta-cell function |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory response to study bagels | Questionnaires will be used to measure the participants' responses to the aroma, appearance, taste and texture of the study bagels. | Days 15, 29, 43 and 57 of both treatment periods |
| Resistant starch bagel tolerance |
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 | Study Director |
| Alison M Duncan, Ph.D., R.D. | University of Guelph, Human Nutraceutical Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutraceutical Research Unit | Guelph | Ontario | N1G 2W1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27733521 | Derived | Dainty SA, Klingel SL, Pilkey SE, McDonald E, McKeown B, Emes MJ, Duncan AM. Resistant Starch Bagels Reduce Fasting and Postprandial Insulin in Adults at Risk of Type 2 Diabetes. J Nutr. 2016 Nov;146(11):2252-2259. doi: 10.3945/jn.116.239418. Epub 2016 Oct 12. |
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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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| ID | Term |
|---|---|
| D000084922 | Resistant Starch |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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Data will be used from 3-hour oral glucose tolerance tests performed on days 1 and 57 of both treatment periods.
| Days 1 and 57 of both treatment periods |
| Satiety-producing effect | After study bagel consumption as part of a standard breakfast, questionnaires will be used to quantify subjective measures of satiety, and weighted food records will be used to objectively measure food intake for the rest of the day. | Day 2,3 or 4 of both treatment periods |
Questionnaires about bagel tolerance, including subjective ratings of tolerance and any adverse events will be completed every 2 weeks throughout both treatment periods (adverse events will be recorded as often as needed).
| Days 15, 29, 43 and 57 of both treatment periods |
| Body weight | Body weight will be measures at every study visit. | Days 1, 15, 29, 43 and 57 of both treatment periods |
| Fasting serum lipids | Total-cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides will be measured from fasted blood samples on days 1 and 57 of both treatment periods. | On days 1 and 57 of both treatment periods |
| 3-Day food records | Participants will complete 3-day food records a total of 3 times throughout the study to provide information about their background nutrient intake and dietary habits. | Over 3 days during the week before the study start date, and the week before study day 29 of both treatment periods. |
| D004700 | Endocrine System Diseases |
| Macromolecular Substances |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |