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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01699074
First received: October 1, 2012
Last updated: April 14, 2014
Last verified: April 2014

October 1, 2012
April 14, 2014
May 2013
September 2013   (final data collection date for primary outcome measure)
Effect of KWG on vascular and glycemic measures [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
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)
KWG and glycemia [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
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 Korean White ginseng treatments on peak and postprandial glycemia measures.
Complete list of historical versions of study NCT01699074 on ClinicalTrials.gov Archive Site
Effect of KWG on vascular and glycemic measures [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
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
KWG and Vascular measures [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
To evaluate the acute effect of KWG treatments on aortic and brachial blood pressure To evaluate the acute effect of KWG treatments on arterial stiffness as measured by aortic augmentation index (AIx) 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
KWG and satiety [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
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)
Same as current
 
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Metabolic Syndrome
  • 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
  • Experimental: 1 gram of White Korean Ginseng
    1 gram of White Korean Ginseng
    Intervention: Dietary Supplement: 1 gram of White Korean Ginseng
  • Experimental: 3 grams of White Korean Ginseng
    3 grams of White Korean Ginseng
    Intervention: Dietary Supplement: 3 grams of White Korean Ginseng
  • Experimental: 6 grams of White Korean Ginseng
    6 grams of White Korean Ginseng
    Intervention: Dietary Supplement: 6 grams of White Korean Ginseng
  • Placebo Comparator: 3 grams of Wheat Bran Control
    3 grams of Wheat Bran Control
    Intervention: Dietary Supplement: 3 grams of Wheat Bran Control
  • Active Comparator: 500mg of Korean Red Ginseng
    500mg of Korean Red Ginseng
    Intervention: Dietary Supplement: 500mg of Korean Red Ginseng
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2014
September 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01699074
182629
Not Provided
St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Not Provided
Not Provided
St. Michael's Hospital, Toronto
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP