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

NCT ID: NCT00728221

Last Updated: 2017-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Blood Pressure Endothelial Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo capsules (3g)

Group Type PLACEBO_COMPARATOR

Cornstarch

Intervention Type DIETARY_SUPPLEMENT

Placebo

2

Whole Korean Red Ginseng root (3g)

Group Type EXPERIMENTAL

Korean Red Ginseng

Intervention Type DIETARY_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)

3

Ginsenoside fraction of Korean Red Ginseng B (0.22g); bioequivalent to the original whole KRG root

Group Type EXPERIMENTAL

Korean Red Ginseng (Panax ginseng)

Intervention Type 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

4

Polysaccharide fraction of KRG root (0.21g); bioequivalent to the original whole KRG root

Group Type EXPERIMENTAL

Korean Red Ginseng (Panax Ginseng)

Intervention Type 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

Interventions

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Korean 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)

Intervention Type DIETARY_SUPPLEMENT

Korean 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

Intervention Type DIETARY_SUPPLEMENT

Cornstarch

Placebo

Intervention Type DIETARY_SUPPLEMENT

Korean 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Kyonggi-do Farm C. A. Meyer Kyonggi-do Farm C. A. Meyer Kyonggi-do Farm C. A. Meyer

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir Vuksan, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto

Alexandra Jenkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. Michael's Hospital Clinical Nutrition and Risk Factor Modification Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Jovanovski E, Peeva V, Sievenpiper JL, Jenkins AL, Desouza L, Rahelic D, Sung MK, Vuksan V. Modulation of endothelial function by Korean red ginseng (Panax ginseng C.A. Meyer) and its components in healthy individuals: a randomized controlled trial. Cardiovasc Ther. 2014 Aug;32(4):163-9. doi: 10.1111/1755-5922.12077.

Reference Type BACKGROUND
PMID: 24758417 (View on PubMed)

Jovanovski E, Jenkins A, Dias AG, Peeva V, Sievenpiper J, Arnason JT, Rahelic D, Josse RG, Vuksan V. Effects of Korean red ginseng (Panax ginseng C.A. Mayer) and its isolated ginsenosides and polysaccharides on arterial stiffness in healthy individuals. Am J Hypertens. 2010 May;23(5):469-72. doi: 10.1038/ajh.2010.5. Epub 2010 Feb 4.

Reference Type RESULT
PMID: 20134405 (View on PubMed)

Other Identifiers

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118328

Identifier Type: -

Identifier Source: org_study_id

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