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

NCT ID: NCT00728403

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2015-08-31

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).

Conditions

Diabetes Mellitus Type 2

Study Design

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

Study Groups

1

American Ginseng and American Red Ginseng Capsules

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

2

American Ginseng Capsules

Group Type: EXPERIMENTAL

American Ginseng (Panax quinquefolius L.)

Intervention Type: DIETARY_SUPPLEMENT

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

3

Placebo Capsules

Group Type: PLACEBO_COMPARATOR

Wheat Bran

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Diabetes Association

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir Vuksan, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutritian and Risk Factor Modification Centre

Alexandra Jenkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition and Risk Factor Modificatrion Centre

Lawerence Leiter, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michaels Hospital

Leanne De Souza, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition and Risk Factor Modificatrion Centre

Locations

Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

122380

Identifier Type: -

Identifier Source: org_study_id