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The study is a Phase-I like double blind randomized placebo controlled crossover design trial. The objective is to assess the dose response relationship on glycemic and vascular effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2 Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria: as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be recruited for the study.
This study hypothesizes that KWG will dose dependently lower postprandial area under the curve compared to negative control, as well as will dose dependently decrease postprandial glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial blood pressure, aortic augmentation index, and mean arterial pressure, and improve left ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to control. Finally, it expects to notice an effect on subjective satiety levels and have no significant adverse effects compared to control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 gram of White Korean Ginseng | Experimental | 1 gram of White Korean Ginseng |
|
| 3 grams of White Korean Ginseng | Experimental | 3 grams of White Korean Ginseng |
|
| 6 grams of White Korean Ginseng | Experimental | 6 grams of White Korean Ginseng |
|
| 3 grams of Wheat Bran Control | Placebo Comparator | 3 grams of Wheat Bran Control |
|
| 500mg of Korean Red Ginseng | Active Comparator | 500mg of Korean Red Ginseng |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 gram of White Korean Ginseng | Dietary Supplement | 1 gram of White Korean Ginseng |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of KWG on vascular and glycemic measures | To evaluate the acute dose response effect of KWG on blood glucose Area under the Curve (AUC) compared to controls in individuals with Metabolic syndrome or Type 2 Diabetes To evaluate the acute effect of KWG treatments on arterial stiffness as measured by aortic augmentation index (AIx) | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of KWG on vascular and glycemic measures | To evaluate the acute effect of Korean White ginseng treatments on peak and postprandial glycemia measures.To evaluate the acute effect of KWG treatments on aortic and brachial blood pressure To evaluate the acute effect of KWG treatments on heart rate, mean arterial pressure, left ventricular ejection duration (ED) and subendocardial viability ratio (SEVR) - a surrogate marker of myocardial perfusion |
| Measure | Description | Time Frame |
|---|---|---|
| KWG and satiety | To evaluate the acute effect of KWG treatments on subjective satiety scores to determine any potential effects on appetite control mechanisms compared to controls. Symptoms questionnaire will assess potential adverse effects of treatments (safety) | 4 hours |
Inclusion Criteria:
Exclusion Criteria:
The use of additional NHPs that may affect blood pressure or blood glucose Individuals suffering from glucose-galactose malabsorption syndrome.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| : Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25136536 | Derived | Shishtar E, Jovanovski E, Jenkins A, Vuksan V. Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Vascular and Glycemic Health in Type 2 Diabetes: Results of a Randomized, Double Blind, Placebo-controlled, Multiple-crossover, Acute Dose Escalation Trial. Clin Nutr Res. 2014 Jul;3(2):89-97. doi: 10.7762/cnr.2014.3.2.89. Epub 2014 Jul 29. |
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| 3 grams of White Korean Ginseng | Dietary Supplement | 3 grams of White Korean Ginseng |
|
| 6 grams of White Korean Ginseng | Dietary Supplement | 6 grams of White Korean Ginseng |
|
| 3 grams of Wheat Bran Control | Dietary Supplement | 3 grams of Wheat Bran Control |
|
| 500mg of Korean Red Ginseng | Dietary Supplement | 500mg of Korean Red Ginseng |
|
| 4 hours |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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