Ginsenoside Improve Metabolic Syndrome

NCT ID: NCT02034136

Last Updated: 2014-01-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

Brief Summary

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Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters such as cholesterol, blood pressure and glucose.

Randomized Control Trial.

Detailed Description

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Methods : A randomized, double-blind, placebo-controlled, single-center study in 60 subjects who are not taking drugs that could affect metabolic and vascular function. Subjects will be randomized into a Korean red ginseng (3.0g/d) group or placebo group for a 4-week study.

We will collect anthropometric measurements, blood for laboratory testing, inflammatory marker, hormones and mitochondrial DNA copy number.

Subject : Older than 40 years of age, presented with metabolic syndrome. Subjects were excluded if they were taking drugs that could affect metabolic and vascular function, including BP control drug, anti-diabetic drugs and lipid-lowering drugs.

Measurement : We will collect anthropometric measurements and blood for laboratory testing at the initial(week 0) and final (week 4)visits. Serum levels of blood glucose, insulin, total cholesterol, HDL-cholesterol,triglyceride, and DNA copy number of mitochondria.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ginsenoside

Ginsenoside :

Intervention : ginsenoside, 3 gram / day, for 28 days in intervention group

Group Type EXPERIMENTAL

Ginsenoside

Intervention Type DIETARY_SUPPLEMENT

3.0 g/ d for 28 days

Dietary fiber fill

Dietary fiber fill manufactured to mimic Ginsenoside tablet

Group Type PLACEBO_COMPARATOR

Dietary fiber fill

Intervention Type DIETARY_SUPPLEMENT

3g/day, 28days

Interventions

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Ginsenoside

3.0 g/ d for 28 days

Intervention Type DIETARY_SUPPLEMENT

Dietary fiber fill

3g/day, 28days

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ginseng fill

Eligibility Criteria

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Inclusion Criteria

* metabolic syndrome

Exclusion Criteria

* Taking drug for lipid-lowering, BP control and anti-diabetic.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Korean Society of Ginseng

OTHER

Sponsor Role collaborator

CHA University

OTHER

Sponsor Role lead

Responsible Party

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Dong-Hyuk Jung

Assistant professor, Family medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DH Jung, MPH.M.D.

Role: PRINCIPAL_INVESTIGATOR

Cha Medical University

Locations

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Bundang CHA Hospital

Seoul, Kyeonggi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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DH Jung, MPH

Role: CONTACT

+82) 10-4204-8998

YJ Lee, Ph.D

Role: CONTACT

+82) 3015-2011

Facility Contacts

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HG Park, PhD

Role: primary

References

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Park BJ, Lee YJ, Lee HR, Jung DH, Na HY, Kim HB, Shim JY. Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects with Metabolic Syndrome: a Double-blind Randomized Controlled Study. Korean J Fam Med. 2012 Jul;33(4):190-6. doi: 10.4082/kjfm.2012.33.4.190. Epub 2012 Jul 25.

Reference Type BACKGROUND
PMID: 22916320 (View on PubMed)

Rasheed N, Tyagi E, Ahmad A, Siripurapu KB, Lahiri S, Shukla R, Palit G. Involvement of monoamines and proinflammatory cytokines in mediating the anti-stress effects of Panax quinquefolium. J Ethnopharmacol. 2008 May 8;117(2):257-62. doi: 10.1016/j.jep.2008.01.035. Epub 2008 Feb 8.

Reference Type BACKGROUND
PMID: 18339495 (View on PubMed)

Lamers F, Vogelzangs N, Merikangas KR, de Jonge P, Beekman AT, Penninx BW. Evidence for a differential role of HPA-axis function, inflammation and metabolic syndrome in melancholic versus atypical depression. Mol Psychiatry. 2013 Jun;18(6):692-9. doi: 10.1038/mp.2012.144. Epub 2012 Oct 23.

Reference Type BACKGROUND
PMID: 23089630 (View on PubMed)

Yun SN, Ko SK, Lee KH, Chung SH. Vinegar-processed ginseng radix improves metabolic syndrome induced by a high fat diet in ICR mice. Arch Pharm Res. 2007 May;30(5):587-95. doi: 10.1007/BF02977653.

Reference Type BACKGROUND
PMID: 17615678 (View on PubMed)

Kim JH, Lee DC. Mitochondrial DNA copy number in peripheral blood is associated with femoral neck bone mineral density in postmenopausal women. J Rheumatol. 2012 Jul;39(7):1465-72. doi: 10.3899/jrheum.111444. Epub 2012 May 15.

Reference Type BACKGROUND
PMID: 22589267 (View on PubMed)

Jung DH, Lee YJ, Kim CB, Kim JY, Shin SH, Park JK. Effects of ginseng on peripheral blood mitochondrial DNA copy number and hormones in men with metabolic syndrome: A randomized clinical and pilot study. Complement Ther Med. 2016 Feb;24:40-6. doi: 10.1016/j.ctim.2015.12.001. Epub 2015 Dec 4.

Reference Type DERIVED
PMID: 26860800 (View on PubMed)

Related Links

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http://www.ginsengsociety.org/

The goal of Korean ginsengsociety is to help elevate the level of ginseng science in both theory and practice by providing technical information to the ginseng industry, providing ginseng-related education to the community.

Other Identifiers

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DH-13722

Identifier Type: -

Identifier Source: org_study_id

BD2013-104

Identifier Type: OTHER

Identifier Source: secondary_id

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