Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes

Long Term Metabolic and Therapeutic Effects of Combined Treatment of American Ginseng (Panax Quinquefolius L.) Extract and Korean Red Ginseng (Steamed Panax C.A. Meyer) Extract in the Treatment of Type 2 Diabetes

The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2 diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study (36 men and 36 post-menopausal women).

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Dietary supplement: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer); Dietary supplement: American Ginseng (Panax quinquefolius L.); Dietary supplement: Wheat Bran

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 1N8
      • Clinical Nutrition and Risk Factor Modification Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• presence of type 2 diabetes (at least 1 year) as defined by A1c between ≥6.5% and ≤8.1%, at recruitment,
• treatment with diet or oral hypoglycemic medication be unchanged starting at least 2 months prior to the beginning of the study (at recruitment, week -8)
• between the age of 40 and 75 years
• systolic blood pressure <140 and diastolic blood pressure <90
• clinically euthyroid (measuring T3 and T4)
• normal renal and liver functions
• post-menopausal or non-pregnant women (Post-menopausal includes: those females with more than a year of cessation of menstruation)
• a negative result on a pregnancy test administered at screening
• subjects taking an effective form of birth control (example: condom, abstinence, etc.)
• willing to comply with the study protocol and sign a consent form

Exclusion Criteria:

• individuals with bleeding disorders
• individuals with allergies to nitroglycerin
• planned surgery, pregnancy or breastfeeding
• taking insulin; clinically significant diabetes complications (retinopathy, nephropathy, or neuropathy); serum triglycerides ≥ 4.5 mmol/L
• increased A1c level of more than 2% from baseline during the study
• history of angina or heart attack
• use of ginseng or any natural health products with glucose modulating and/or anti-platelet activity within 2 months
• BMI > 35 kg/m2 including a weight fluctuation of + 2kg during treatment periods
• smoke cigarettes; alcohol intake > 2 drinks/day
• the presence of any conditions which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel or adversely affect the study results, if the subject participated in the study
• Subjects taking Warfarin or Coumadin, prescription NSAIDs, chronic use of high-dose (>81mg) non-prescription NSAIDs, or selective serotonin reuptake inhibitors and monoamine oxidase inhibitors, or sympathomimetics or medications affecting nitric oxide levels, or any known or suspected sensitivity to any of the ingredients in the test product or placebo cannot participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; American Ginseng and American Red Ginseng Capsules	Dietary supplement: American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer); 1.5 grams American Ginseng and 1.5 grams Korean Red Ginseng are to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks
Experimental: 2; American Ginseng Capsules	Dietary supplement: American Ginseng (Panax quinquefolius L.); 3 grams of American Ginseng is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks
Placebo Comparator: 3; Placebo Capsules	Dietary supplement: Wheat Bran; 3 grams of Wheat Bran is to be taken in capsulated form. Two capsules are taken with every meal, for a total of 6 capsules per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI	Weeks -4, 0, 6, 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition	Weeks -4, 0, 6, 12

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Canadian Diabetes Association
• Investigators: Principal Investigator: Vladimir Vuksan, PhD, Clinical Nutritian and Risk Factor Modification Centre; Principal Investigator: Alexandra Jenkins, PhD, Clinical Nutrition and Risk Factor Modificatrion Centre; Principal Investigator: Lawerence Leiter, MD, St. Michaels Hospital; Principal Investigator: Leanne De Souza, M.Sc., Clinical Nutrition and Risk Factor Modificatrion Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: August 1, 2008
• First Submitted That Met QC Criteria: August 4, 2008
• First Posted (Estimate): August 5, 2008

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 122380