Clinical trial NCT01699074: Acute Dose Response of Korean White Ginseng in Metabolic Syndrome or Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Metabolic Syndrome
Keywords: Korean White Ginseng
Type 2 diabetes
Metabolic syndrome
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Men and women
* 18-75 years old
* BMI 25-35 kg/m2
* Presence of type 2 diabetes (as defined by HbA1c ≤8.5%),treatment with diet or oral hypoglycemic medication) OR
* Presence of Metabolic Syndrome as defined by The US National Cholesterol -Education Program Adult Treatment Panel III (NCEP III). As per NCEP III criteria, at least three of the following must be present:
* central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches(female)
* dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl);
* dyslipidemia: HDL-C \< 40 mg/dL (male), \< 50 mg/dL (female) blood pressure ≥ 130/85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)

Exclusion Criteria:

* BMI \>35 kg/m2
* Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
* Pregnant women, or those at risk of pregnancy, or breastfeeding at the time of the study.
* Women of childbearing age that do not use acceptable method of birth control (ie. abstinence, implants, injectables, oral contraceptives, IUDs etc).
* Chronic conditions including: liver disease, cancer, heavy alcohol use, bleeding disorders, history of angina, congestive heart failure, coronary revascularization, peripheral vascular disease, retinopathy, kidney disease or coronary/cerebrovascular event; chronic use of medications including blood-thinners, SSRIs, MAO inhibitors, medications affecting NO synthesis (eg. Viagra)
* Allergy or sensitivity to the placebo (wheat bran), ginseng or gelatin used in the capsules.
* Use of any ginseng products within three days preceding the study and during the study.
* Allergies to Panax species, their constituents or to other members of the Araliaceae family.

The use of additional NHPs that may affect blood pressure or blood glucose Individuals suffering from glucose-galactose malabsorption syndrome.

Primary outcomes:
measure: Effect of KWG on vascular and glycemic measures
timeFrame: 3 hours
Secondary outcomes:
measure: Effect of KWG on vascular and glycemic measures
timeFrame: 4 hours
Other outcomes:
measure: KWG and satiety
timeFrame: 4 hours
Locations:
city: Toronto
country: Canada
facility: : Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
state: Ontario
Study officials:
References:
citation: 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.