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| Name | Class |
|---|---|
| Canadian Diabetes Association | OTHER |
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The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2 diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study (36 men and 36 post-menopausal women).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | American Ginseng and American Red Ginseng Capsules |
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| 2 | Experimental | American Ginseng Capsules |
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| 3 | Placebo Comparator | Placebo Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer) | Dietary Supplement | 1.5 grams American Ginseng and 1.5 grams Korean Red Ginseng are to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI | Weeks -4, 0, 6, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition | Weeks -4, 0, 6, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Vuksan, PhD | Clinical Nutritian and Risk Factor Modification Centre | Principal Investigator |
| Alexandra Jenkins, PhD | Clinical Nutrition and Risk Factor Modificatrion Centre | Principal Investigator |
| Lawerence Leiter, MD | St. Michaels Hospital | Principal Investigator |
| Leanne De Souza, M.Sc. | Clinical Nutrition and Risk Factor Modificatrion Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition and Risk Factor Modification Centre | Toronto | Ontario | M5C 1N8 | Canada |
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| American Ginseng (Panax quinquefolius L.) | Dietary Supplement | 3 grams of American Ginseng is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks |
|
| Wheat Bran | Dietary Supplement | 3 grams of Wheat Bran is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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