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

NCT00728221 | Completed Phase 2

• 1 other identifier: 118328
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Blood Pressure; Endothelial Function

Keywords

Ginseng; Korean Red Ginseng; Ginsenoside; Flow Mediated Dilation; Endothelial Function; Hypertension

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilation of the brachial artery

  Start and finish of each treatment arm

Secondary Outcomes (2)

• Augmentation Index

  Start and finish of each treatment arm

• Nitric Oxide and Cyclic GMP

  Beginning of and 3 hours into clinical visit

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo capsules (3g)

Dietary Supplement: Cornstarch

2

EXPERIMENTAL

Whole Korean Red Ginseng root (3g)

Dietary Supplement: Korean Red Ginseng

3

EXPERIMENTAL

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

Dietary Supplement: Korean Red Ginseng (Panax ginseng)

4

EXPERIMENTAL

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

Dietary Supplement: Korean Red Ginseng (Panax Ginseng)

Interventions

Korean Red Ginseng 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)

Also known as: Kyonggi-do Farm, C. A. Meyer

2

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

Also known as: Kyonggi-do Farm, C. A. Meyer

3

Cornstarch DIETARY_SUPPLEMENT

Placebo

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: between 18 and 70 years of age
• Healthy individuals (absence of major illnesses)

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

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

Toronto, Ontario, M5C 1N8, Canada

Location

Related Publications (2)

• 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.

  PMID: 24758417 BACKGROUND

• 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.

  PMID: 20134405 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Asian ginseng; Starch

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Vladimir Vuksan, PhD

  St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

• Alexandra Jenkins, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2008
• First Posted: August 5, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

CA (1)