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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: 1 gram of White Korean Ginseng; Dietary supplement: 3 grams of White Korean Ginseng; Dietary supplement: 6 grams of White Korean Ginseng; Dietary supplement: 3 grams of Wheat Bran Control; Dietary supplement: 500mg of Korean Red Ginseng

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • : Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 gram of White Korean Ginseng	Dietary supplement: 1 gram of White Korean Ginseng; 1 gram of White Korean Ginseng
Experimental: 3 grams of White Korean Ginseng	Dietary supplement: 3 grams of White Korean Ginseng; 3 grams of White Korean Ginseng
Experimental: 6 grams of White Korean Ginseng	Dietary supplement: 6 grams of White Korean Ginseng; 6 grams of White Korean Ginseng
Placebo Comparator: 3 grams of Wheat Bran Control	Dietary supplement: 3 grams of Wheat Bran Control; 3 grams of Wheat Bran Control
Active Comparator: 500mg of Korean Red Ginseng	Dietary supplement: 500mg of Korean Red Ginseng; 500mg of Korean Red Ginseng

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Type 2 diabetes; Korean White Ginseng
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 182629