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
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedApril 15, 2014
April 1, 2014
4 months
October 1, 2012
April 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Effect of KWG on vascular and glycemic measures
4 hours
Other Outcomes (1)
KWG and satiety
4 hours
Study Arms (5)
1 gram of White Korean Ginseng
EXPERIMENTAL1 gram of White Korean Ginseng
3 grams of White Korean Ginseng
EXPERIMENTAL3 grams of White Korean Ginseng
6 grams of White Korean Ginseng
EXPERIMENTAL6 grams of White Korean Ginseng
3 grams of Wheat Bran Control
PLACEBO COMPARATOR3 grams of Wheat Bran Control
500mg of Korean Red Ginseng
ACTIVE COMPARATOR500mg of Korean Red Ginseng
Interventions
1 gram of White Korean Ginseng
3 grams of White Korean Ginseng
6 grams of White Korean Ginseng
3 grams of Wheat Bran Control
Eligibility Criteria
You may qualify if:
- Men and women
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Related Publications (1)
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.
PMID: 25136536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 3, 2012
Study Start
May 1, 2013
Primary Completion
September 1, 2013
Study Completion
January 1, 2014
Last Updated
April 15, 2014
Record last verified: 2014-04