Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes (R-KAT)

• Change from Baseline in Mean 24 hour Diastolic Ambulatory Blood pressure at 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change in Pulse Pressure [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change in Central Augmentation Index [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change from Baseline in Pulse Wave Velocity at 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change in low-grade body inflammation (hs-CRP) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change in HbA1c [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change in Fasting Insulin [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change in Fasting Glucose [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Change in Calculated HOMA-Insulin Sensitivity [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind randomized placebo controlled trial. The objective is to investigate whether the combination of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are effective and safe in the long-term management of high blood pressure while managing type 2 diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key inclusion criteria: HbA1c ≥ 7.0%- ≤ 8.0%) will be recruited for the study.

• Diabetes Mellitus Type 2
• Hypertension

• Dietary Supplement: Ginseng
  2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
• Dietary Supplement: Wheat Bran
  2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).

• Experimental: Ginseng
  Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
  Intervention: Dietary Supplement: Ginseng
• Placebo Comparator: Wheat Bran
  100 % Natural Wheat Bran capsule
  Intervention: Dietary Supplement: Wheat Bran

Inclusion Criteria:

• between the age of 40 and 75 years
• type 2 diabetes (at least 1 year duration, HbA1c ≥ 7.0%- ≤ 8.0%, treated with diet and/or oral hypoglycemic medications)
• clinically diagnosed and treated hypertension according to Canadian Diabetes Association Clinical Practice Guidelines
• normal thyroid, kidney and liver functions
• female subjects recruited for the study must be post-menopausal or had absence of menstruation for ≥ 1 year or is taking contraceptive precautions

Exclusion Criteria:

• insulin therapy
• history of angina, myocardial infarction or stroke
• systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg
• use of ginseng within 1 month start of study
• BMI >35 kg/m2
• smoking cigarettes
• alcohol intake of > 2 drinks/day
• recently given blood
• have an upcoming planned surgery
• GFR <60 mL/min/1.73m2
• prolonged QT (>20 ms) interval as assessed by ECG
• changes to use of natural health products that may effect blood pressure and/or diabetes
• weight change more than +/- 3 kg/month
• HIV infection, inflammatory bowel disease, celiac disease, heart disease, bleeding disorder, sleep disorder, arrhythmia
• pregnant or breastfeeding
• use of anticoagulant (excluding aspirin), antiplatelet, sedative, sympathomimetic, photosensitizing or anti-depressant drugs
• hormone replacement therapy, furosemide, morphine, glucocorticoids
• presence of any conditions which, in the opinion of the Qualified Investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
• known sensitivity or allergy to any test product or placebo ingredients