: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
NCT Number: NCT01699074
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Toronto, Ontario, M5B 1W8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The use of additional NHPs that may affect blood pressure or blood glucose Individuals suffering from glucose-galactose malabsorption syndrome.
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
Time frame: 3 hours
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: 4 hours
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
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)
Unity Health Toronto
Other
Acute Dose Response Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Cardiovascular Disease Risk Factors in Individuals With Metabolic Syndrome or Type 2 Diabetes
Acronym: KWG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01283113
Body Weight, Diabetes Mellitus
Boston, Massachusetts, United States
View Trial DetailsNCT04148482
Behavior, Behavior, Animal
Boston, Massachusetts, United States
View Trial DetailsNCT06350604
Behavior, Cardiovascular Diseases
Glassboro, New Jersey, United States
View Trial DetailsNCT02481466
Behavior, Cardiovascular Diseases
Vancouver, British Columbia, Canada
View Trial Details