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

NCT ID: NCT01699074

Last Updated: 2014-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-01-31

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.

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.

Conditions

Type 2 Diabetes; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1 gram of White Korean Ginseng

1 gram of White Korean Ginseng

Group Type: EXPERIMENTAL

1 gram of White Korean Ginseng

Intervention Type: DIETARY_SUPPLEMENT

1 gram of White Korean Ginseng

3 grams of White Korean Ginseng

3 grams of White Korean Ginseng

Group Type: EXPERIMENTAL

3 grams of White Korean Ginseng

Intervention Type: DIETARY_SUPPLEMENT

3 grams of White Korean Ginseng

6 grams of White Korean Ginseng

6 grams of White Korean Ginseng

Group Type: EXPERIMENTAL

6 grams of White Korean Ginseng

Intervention Type: DIETARY_SUPPLEMENT

6 grams of White Korean Ginseng

3 grams of Wheat Bran Control

3 grams of Wheat Bran Control

Group Type: PLACEBO_COMPARATOR

3 grams of Wheat Bran Control

Intervention Type: DIETARY_SUPPLEMENT

3 grams of Wheat Bran Control

500mg of Korean Red Ginseng

500mg of Korean Red Ginseng

Group Type: ACTIVE_COMPARATOR

500mg of Korean Red Ginseng

Intervention Type: DIETARY_SUPPLEMENT

500mg of Korean Red Ginseng

Interventions

1 gram of White Korean Ginseng

1 gram of White Korean Ginseng

Intervention Type: DIETARY_SUPPLEMENT

3 grams of White Korean Ginseng

3 grams of White Korean Ginseng

Intervention Type: DIETARY_SUPPLEMENT

6 grams of White Korean Ginseng

6 grams of White Korean Ginseng

Intervention Type: DIETARY_SUPPLEMENT

3 grams of Wheat Bran Control

3 grams of Wheat Bran Control

Intervention Type: DIETARY_SUPPLEMENT

500mg of Korean Red Ginseng

500mg of Korean Red Ginseng

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25136536 (View on PubMed)

Other Identifiers

182629

Identifier Type: -

Identifier Source: org_study_id