Diabetes Mellitus Type 2
Conditions
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).
Interventions
DIETARY_SUPPLEMENTAmerican 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
DIETARY_SUPPLEMENTAmerican 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
DIETARY_SUPPLEMENTWheat 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
Sponsors
Canadian Diabetes Association
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI | Weeks -4, 0, 6, 12 |
Secondary
| 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 |
Countries
Canada
Outcome results
None listed