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

Primary Purpose

Diabetes Mellitus Type 2

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)

American Ginseng (Panax quinquefolius L.)

Wheat Bran

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

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

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.

Sites / Locations

Clinical Nutrition and Risk Factor Modification Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

American Ginseng and American Red Ginseng Capsules

American Ginseng Capsules

Placebo Capsules

Outcomes

Primary Outcome Measures

HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI

Secondary Outcome Measures

Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition

Full Information

NCT ID

NCT00728403

First Posted

August 1, 2008

Last Updated

July 30, 2015

Sponsor

Unity Health Toronto

Collaborators

Canadian Diabetes Association

1. Study Identification

Unique Protocol Identification Number

NCT00728403

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Canadian Diabetes Association

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

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

Diabetes Mellitus Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

American Ginseng and American Red Ginseng Capsules

Arm Title

Arm Type

Experimental

Arm Description

American Ginseng Capsules

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo Capsules

Intervention Type

Dietary Supplement

Intervention Name(s)

American Ginseng (Panax quinquefolius L.) and Korean Red Ginseng (steamed Panax C.A. Meyer)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

American Ginseng (Panax quinquefolius L.)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Wheat Bran

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI

Time Frame

Weeks -4, 0, 6, 12

Secondary Outcome Measure Information:

Title

Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition

Time Frame

Weeks -4, 0, 6, 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vladimir Vuksan, PhD

Organizational Affiliation

Clinical Nutritian and Risk Factor Modification Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alexandra Jenkins, PhD

Organizational Affiliation

Clinical Nutrition and Risk Factor Modificatrion Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lawerence Leiter, MD

Organizational Affiliation

St. Michaels Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leanne De Souza, M.Sc.

Organizational Affiliation

Clinical Nutrition and Risk Factor Modificatrion Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Nutrition and Risk Factor Modification Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 1N8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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