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

Primary Purpose

Type 2 Diabetes, Metabolic Syndrome

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

1 gram of White Korean Ginseng

3 grams of White Korean Ginseng

6 grams of White Korean Ginseng

3 grams of Wheat Bran Control

500mg of Korean Red Ginseng

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Korean White Ginseng, Type 2 diabetes, Metabolic syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

1 gram of White Korean Ginseng

3 grams of White Korean Ginseng

6 grams of White Korean Ginseng

3 grams of Wheat Bran Control

500mg of Korean Red Ginseng

Arm Description

1 gram of White Korean Ginseng

3 grams of White Korean Ginseng

6 grams of White Korean Ginseng

3 grams of Wheat Bran Control

500mg of Korean Red Ginseng

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01699074

First Posted

October 1, 2012

Last Updated

April 14, 2014

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01699074

Brief Title

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

Acronym

KWG

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Metabolic Syndrome

Keywords

Korean White Ginseng, Type 2 diabetes, Metabolic syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 gram of White Korean Ginseng

Arm Type

Experimental

Arm Description

1 gram of White Korean Ginseng

Arm Title

3 grams of White Korean Ginseng

Arm Type

Experimental

Arm Description

3 grams of White Korean Ginseng

Arm Title

6 grams of White Korean Ginseng

Arm Type

Experimental

Arm Description

6 grams of White Korean Ginseng

Arm Title

3 grams of Wheat Bran Control

Arm Type

Placebo Comparator

Arm Description

3 grams of Wheat Bran Control

Arm Title

500mg of Korean Red Ginseng

Arm Type

Active Comparator

Arm Description

500mg of Korean Red Ginseng

Intervention Type

Dietary Supplement

Intervention Name(s)

1 gram of White Korean Ginseng

Intervention Description

1 gram of White Korean Ginseng

Intervention Type

Dietary Supplement

Intervention Name(s)

3 grams of White Korean Ginseng

Intervention Description

3 grams of White Korean Ginseng

Intervention Type

Dietary Supplement

Intervention Name(s)

6 grams of White Korean Ginseng

Intervention Description

6 grams of White Korean Ginseng

Intervention Type

Dietary Supplement

Intervention Name(s)

3 grams of Wheat Bran Control

Intervention Description

3 grams of Wheat Bran Control

Intervention Type

Dietary Supplement

Intervention Name(s)

500mg of Korean Red Ginseng

Intervention Description

500mg of Korean Red Ginseng

Primary Outcome Measure Information:

Title

Effect of KWG on vascular and glycemic measures

Description

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Effect of KWG on vascular and glycemic measures

Description

Time Frame

4 hours

Other Pre-specified Outcome Measures:

Title

KWG and satiety

Description

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)

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

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

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25136536

Citation

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.

Results Reference

derived

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

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