Hypertension, Blood Pressure, Endothelial Function
Conditions
Keywords
Ginseng, Korean Red Ginseng, Ginsenoside, Flow Mediated Dilation, Endothelial Function, Hypertension
Brief summary
Ginseng has been used for many years in a wide array of anecdotal medicinal properties. Animal and limited clinical research points to the vascular effects of Korean Red Ginseng (KRG). The present project aims to assess the efficacy of KRG and contribution of its factionated components on various indices of vascular function in healthy individuals. Our primary objective is to compare the acute effects of KRG and placebo on endothelial function. Moreover, our secondary objective is to evaluate the effect of isolated KRG factions on arterial stiffness, blood pressure and vasoactive markers. We hypothesize that (1) consumption of KRG will cause an improvement in endothelial function in healthy individuals, as compared to placebo; (2) consumption of KRG will cause an improvement in arterial stiffness and blood pressure in healthy individuals, as compared to placebo; (3) the ginsenoside faction of KRG is primarily responsible for the anticipated vascular effects.
Interventions
DIETARY_SUPPLEMENTKorean Red Ginseng
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: whole root in capsules (3g)
DIETARY_SUPPLEMENTKorean Red Ginseng (Panax ginseng)
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total ginsenoside fraction in capsules
DIETARY_SUPPLEMENTCornstarch
Placebo
DIETARY_SUPPLEMENTKorean Red Ginseng (Panax Ginseng)
Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total polysaccharide fraction (panaxans) in capsules
Sponsors
Heart and Stroke Foundation of Canada
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: between 18 and 70 years of age * Healthy individuals (absence of major illnesses)
Exclusion criteria
* Primary hypertension (defined by the use of antihypertensive agents or a seated systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than 90mmHg) * Secondary hypertension (defined as SBP greater than 180mmHg and DBP greater than 110mmHg) * Grade 3 hypertension (defined as SBP greater than 180mmHg and DBP greater than 110mmHg) * Diabetes * Chronic kidney disease * Liver disease * Estrogen-sensitive cancer * Heavy alcohol use * Bleeding disorders * Planned surgery * Angina * CHF * Coronary revascularization * Peripheral vascular disease * Coronary/cerebrovascular event in the last 6 months * Prescriptions of MAO inhibitors, SSRIs, diuretics, sympathomimetics, herbal therapies, medication affecting nitric oxide synthesis, and/or anticoagulent medications within the last 6 months * Sensitivity to any of the ingredients in the treatments or placebo * Chronic use of or frequent prescriptions for NSAIDs * Women of childbearing potential must not be pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-mediated dilation of the brachial artery | Start and finish of each treatment arm |
Secondary
| Measure | Time frame |
|---|---|
| Augmentation Index | Start and finish of each treatment arm |
| Nitric Oxide and Cyclic GMP | Beginning of and 3 hours into clinical visit |
Countries
Canada
Outcome results
None listed