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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Metabolic Syndrome
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
Phase 1

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

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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)


Enrollment: 30
Study Start Date: May 2013
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 gram of White Korean Ginseng
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
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
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
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
500mg of Korean Red Ginseng
Dietary Supplement: 500mg of Korean Red Ginseng
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01699074

Locations
Canada, Ontario
: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01699074     History of Changes
Other Study ID Numbers: 182629
Study First Received: October 1, 2012
Last Updated: April 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Korean White Ginseng
Type 2 diabetes
Metabolic syndrome

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on July 24, 2014