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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
1 gram of White Korean Ginseng
3 grams of White Korean Ginseng
6 grams of White Korean Ginseng
3 grams of Wheat Bran Control
500mg of Korean Red Ginseng
: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada
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)
Time frame: 3 hours
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
Time frame: 4 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.