Effect of Korean Red Ginseng Extract on Blood Flow in Healthy Adults

NCT06236243 | Completed

• 1 other identifier: K04-23-01-T0049
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this clinical trial are to 1) determine the effect of the TP compared to placebo on blood flow and platelet aggregation, 2) to determine the effect of the TP on cardiovascular health compared to a placebo and 3) to assess the safety and tolerability of the TP in healthy adults.

Conditions

Cardiovascular Diseases; Blood Pressure Disorders; Vasodilation; Platelet Aggregation

Keywords

Blood Circulation

Outcome Measures

Primary Outcomes (3)

• Blood Flow

  Between placebo and test products, change from baseline to 6 weeks in flow-mediated dilation of the brachial artery.

  6 weeks

• Blood Flow

  Between placebo and test products, change from baseline to 12 weeks in flow-mediated dilation of the brachial artery.

  12 weeks

• Platelet Aggregation

  Between placebo and test products, change from baseline to 12 weeks in platelet aggregation.

  12 weeks

Secondary Outcomes (59)

• Augmentation Index

  6 weeks

• Augmentation Index

  12 weeks

• Blood Levels of Nitric Oxide

  6 weeks

• Blood Levels of Nitric Oxide

  12 weeks

• Blood Levels Cyclic Guanosine Monophosphate (cGMP)

  6 weeks

Study Arms (3)

G1899 Korean Red Ginseng Extract Powder 120 mg/tablet

ACTIVE COMPARATOR

480 mg of Korean Red Ginseng Extract powder per day for a total of 12 weeks.

Dietary Supplement: Korean Red Ginseng Extract Powder 120 mg/tablet

G1899 Korean Red Ginseng Extract Powder 500 mg/tablet

ACTIVE COMPARATOR

2000 mg of Korean Red Ginseng Extract Powder per day for a total of 12 weeks.

Dietary Supplement: Korean Red Ginseng Extract Powder 500 mg/tablet

Placebo

PLACEBO COMPARATOR

Inactive Ingredients

Dietary Supplement: Placebo

Interventions

Korean Red Ginseng Extract Powder 120 mg/tablet DIETARY_SUPPLEMENT

Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.

G1899 Korean Red Ginseng Extract Powder 120 mg/tablet

Korean Red Ginseng Extract Powder 500 mg/tablet DIETARY_SUPPLEMENT

Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.

G1899 Korean Red Ginseng Extract Powder 500 mg/tablet

Placebo DIETARY_SUPPLEMENT

Participants will take 2 tablets 2 times daily (preferably after breakfast and after dinner) for 12 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (male and female) who are 20 to 75 years of age (inclusive).
• Are able to swallow tablets whole.
• In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator.
• Have acceptable heart rate as assessed by the investigator at screening and baseline.
• Have acceptable levels of blood lipid biomarkers at screening:
• Triglycerides \<200 mg/dL
• Total cholesterol \<240 mg/dL
• LDL cholesterol \<160 mg/dL
• HDL cholesterol \>39 mg/dL (for males) or \>49 mg/dL (females)
• Have resting (seated) systolic blood pressure between 90 to 129 mmHg and diastolic blood pressure between 60 to 79 mmHg (inclusive) at screening and baseline.
• Have a body mass index (BMI) between 18.0 to 34.9 kg/m\^2 (inclusive) at screening.
• Agrees to follow restriction on concomitant treatments as described in the study protocol.
• Agrees to use acceptable contraceptive methods for the study.
• Agrees to follow the restrictions on lifestyle as described in the study protocol.
• Have maintained consistent dietary habits (including supplement intake) and lifestyle for the last 3 months before screening.

You may not qualify if:

• Are lactating, pregnant or planning to become pregnant during the study (e.g., positive pregnancy test at Visit 2).
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients (including lactose).
• Have positive medical history of heart disease/cardiovascular disease, kidney disease (dialysis or renal failure), blood or bleeding disorder, hepatic impairment or disease, thyroid disease, or Type I or Type II diabetes.
• Has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, steatorrhea).
• Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
• Have a positive medical history of immune disorder or is immunocompromised (i.e., HIV/AIDS, Systemic Lupus Erythematosus, etc.), or a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
• Have a positive medical history of psychiatric disorder that required hospitalization in the prior year.
• Report a clinically significant illness during the 28 days before the first dose of study product.
• Have undergone major surgery in 3 months prior to screening or planned major surgery during the study.
• Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), chronic use defined as being taken more than 3 times a week for more than 3 months.
• Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program).
• Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
• Living in the same household as another currently/previously enrolled participant in the present study.
• Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Sponsors & Collaborators

• Korea Ginseng Corporation: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Valiance Clinical Research

Tarzana, California, 91356, United States

Location

Related Publications (7)

• Chen J, Rizzo JA. The economics of cardiovascular disease in the United States. Crit Care Clin. 2012 Jan;28(1):77-88, vi. doi: 10.1016/j.ccc.2011.10.007.

  PMID: 22123100 BACKGROUND

• Hyun SH, Bhilare KD, In G, Park CK, Kim JH. Effects of Panax ginseng and ginsenosides on oxidative stress and cardiovascular diseases: pharmacological and therapeutic roles. J Ginseng Res. 2022 Jan;46(1):33-38. doi: 10.1016/j.jgr.2021.07.007. Epub 2021 Jul 26.

  PMID: 35058725 BACKGROUND

• Irfan M, Kwak YS, Han CK, Hyun SH, Rhee MH. Adaptogenic effects of Panax ginseng on modulation of cardiovascular functions. J Ginseng Res. 2020 Jul;44(4):538-543. doi: 10.1016/j.jgr.2020.03.001. Epub 2020 Mar 28.

  PMID: 32617033 BACKGROUND

• Liu L, Hu J, Mao Q, Liu C, He H, Hui X, Yang G, Qu P, Lian W, Duan L, Dong Y, Pan J, Liu Y, He Q, Li J, Wang J. Functional compounds of ginseng and ginseng-containing medicine for treating cardiovascular diseases. Front Pharmacol. 2022 Dec 2;13:1034870. doi: 10.3389/fphar.2022.1034870. eCollection 2022.

  PMID: 36532771 BACKGROUND

• 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

• Kang J, Lee N, Ahn Y, Lee H. Study on improving blood flow with Korean red ginseng substances using digital infrared thermal imaging and Doppler sonography: randomized, double blind, placebo-controlled clinical trial with parallel design. J Tradit Chin Med. 2013 Feb;33(1):39-45. doi: 10.1016/s0254-6272(13)60098-9.

  PMID: 23596810 BACKGROUND

• Rhee MY, Cho B, Kim KI, Kim J, Kim MK, Lee EK, Kim HJ, Kim CH. Blood pressure lowering effect of Korea ginseng derived ginseol K-g1. Am J Chin Med. 2014;42(3):605-18. doi: 10.1142/S0192415X14500396.

  PMID: 24871654 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Aneurysm

Interventions

Tablets

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Amir H.S. Rafie, MD

  Valiance Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Parallel, Placebo-Controlled

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: January 31, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

US (1)