Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation

Unity Health Toronto17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension Blood Pressure Endothelial Function

Interventions

Korean Red GinsengDIETARY_SUPPLEMENT

Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: whole root in capsules (3g)

Korean Red Ginseng (Panax ginseng)DIETARY_SUPPLEMENT

Cultivated KRG-B (central body Korean Red Ginseng) obtained from Kyonggi-do Farm, Kyonggi-do Province, Korea. Dosage form: total ginsenoside fraction in capsules

CornstarchDIETARY_SUPPLEMENT

Placebo

Korean Red Ginseng (Panax Ginseng)DIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Flow-mediated dilation of the brachial artery

Time frame: Start and finish of each treatment arm

Secondary Outcomes

Augmentation Index