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Ginsenoside Improve Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Ginsenoside

Dietary fiber fill

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

metabolic syndrome

Exclusion Criteria:

Taking drug for lipid-lowering, BP control and anti-diabetic.

Sites / Locations

Bundang CHA Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginsenoside

Dietary fiber fill

Arm Description

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

Dietary fiber fill manufactured to mimic Ginsenoside tablet

Outcomes

Primary Outcome Measures

Change from baseline in metabolic syndrome profile at week 4

Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight

Secondary Outcome Measures

Change from baseline in hormones at week 4.

insulin ,cortisol, testosterone, somatomedin-c and DHEAS

Full Information

NCT ID

NCT02034136

First Posted

July 21, 2013

Last Updated

January 10, 2014

Sponsor

CHA University

Collaborators

The Korean Society of Ginseng

1. Study Identification

Unique Protocol Identification Number

NCT02034136

Brief Title

Ginsenoside Improve Metabolic Syndrome

Official Title

Effects of Ginsenoside Supplementation on Insulin Resistance and Cardiometabolic Risk Factors in Men With Metabolic Syndrome: a Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CHA University

Collaborators

The Korean Society of Ginseng

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ginsenoside

Arm Type

Experimental

Arm Description

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

Arm Title

Dietary fiber fill

Arm Type

Placebo Comparator

Arm Description

Dietary fiber fill manufactured to mimic Ginsenoside tablet

Intervention Type

Dietary Supplement

Intervention Name(s)

Ginsenoside

Other Intervention Name(s)

Ginseng fill

Intervention Description

3.0 g/ d for 28 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary fiber fill

Intervention Description

3g/day, 28days

Primary Outcome Measure Information:

Title

Change from baseline in metabolic syndrome profile at week 4

Description

Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight

Time Frame

Baseline and 4 weeks from intake of Ginsenoside

Secondary Outcome Measure Information:

Title

Change from baseline in hormones at week 4.

Description

insulin ,cortisol, testosterone, somatomedin-c and DHEAS

Time Frame

Initial and 4 weeks later

Other Pre-specified Outcome Measures:

Title

Mitochondria DNA copy number

Time Frame

initial and 4 weeks later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: metabolic syndrome Exclusion Criteria: Taking drug for lipid-lowering, BP control and anti-diabetic.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DH Jung, MPH

Phone

+82) 10-4204-8998

balsan2@empas.com

First Name & Middle Initial & Last Name or Official Title & Degree

YJ Lee, Ph.D

Phone

+82) 3015-2011

ykyjhome@yuhs.ac

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DH Jung, MPH.M.D.

Organizational Affiliation

Cha Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bundang CHA Hospital

City

Seoul

State/Province

Kyeonggi-do

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

HG Park, PhD

irb@chamc.co.kr

First Name & Middle Initial & Last Name & Degree

DH Jung, MPH

12. IPD Sharing Statement

Citations:

PubMed Identifier

22916320

Citation

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.

Results Reference

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PubMed Identifier

18339495

Citation

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.

Results Reference

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PubMed Identifier

23089630

Citation

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.

Results Reference

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PubMed Identifier

17615678

Citation

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.

Results Reference

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PubMed Identifier

22589267

Citation

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.

Results Reference

background

PubMed Identifier

26860800

Citation

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.

Results Reference

derived

Links:

URL

http://www.ginsengsociety.org/

Description

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.

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Ginsenoside Improve Metabolic Syndrome

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