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

Type 2 Diabetes Clinical Trial

— KWG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699074
• Other study ID #: 182629
• Status: Completed
• Phase: Phase 1
• First received: October 1, 2012
• Last updated: April 14, 2014
• Start date: May 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Canada	: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	KWG and satiety	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)	4 hours	No
Primary	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)	3 hours	No
Secondary	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	4 hours	No