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

Unity Health Toronto

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes; Metabolic Syndrome

Treatments: Dietary Supplement: 3 grams of White Korean Ginseng; Dietary Supplement: 1 gram of White Korean Ginseng; Dietary Supplement: 6 grams of White Korean Ginseng; Dietary Supplement: 500mg of Korean Red Ginseng; Dietary Supplement: 3 grams of Wheat Bran Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01699074

182629

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 5 patient groups, including a placebo group

1 gram of White Korean Ginseng

Experimental group

Description:

1 gram of White Korean Ginseng

Treatment:

Dietary Supplement: 1 gram of White Korean Ginseng

3 grams of White Korean Ginseng

Experimental group

Description:

3 grams of White Korean Ginseng

Treatment:

Dietary Supplement: 3 grams of White Korean Ginseng

6 grams of White Korean Ginseng

Experimental group

Description:

6 grams of White Korean Ginseng

Treatment:

Dietary Supplement: 6 grams of White Korean Ginseng

3 grams of Wheat Bran Control

Placebo Comparator group

Description:

3 grams of Wheat Bran Control

Treatment:

Dietary Supplement: 3 grams of Wheat Bran Control

500mg of Korean Red Ginseng

Active Comparator group

Description:

500mg of Korean Red Ginseng

Treatment:

Dietary Supplement: 500mg of Korean Red Ginseng