NCT01699074

Acute Dose Response of Korean White Ginseng in Metabolic Syndrome or Type 2 Diabetes

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes
• Metabolic Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	1 gram of White Korean Ginseng	1 gram of White Korean Ginseng
DIETARY_SUPPLEMENT	3 grams of White Korean Ginseng	3 grams of White Korean Ginseng
DIETARY_SUPPLEMENT	6 grams of White Korean Ginseng	6 grams of White Korean Ginseng
DIETARY_SUPPLEMENT	3 grams of Wheat Bran Control	3 grams of Wheat Bran Control
DIETARY_SUPPLEMENT	500mg of Korean Red Ginseng	500mg of Korean Red Ginseng

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-09-01
• Completion: 2014-01-01
• First posted: 2012-10-03
• Last updated: 2014-04-15

Locations

1 site across 1 country: Canada