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Ginsenoside Improve Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02034136
Recruitment Status : Unknown
Verified January 2014 by Dong-Hyuk Jung, CHA University.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Sponsor:
Collaborator:
The Korean Society of Ginseng
Information provided by (Responsible Party):
Dong-Hyuk Jung, CHA University

Brief Summary:

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

Randomized Control Trial.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Ginsenoside Dietary Supplement: Dietary fiber fill Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ginsenoside Supplementation on Insulin Resistance and Cardiometabolic Risk Factors in Men With Metabolic Syndrome: a Randomized Controlled Trial.
Study Start Date : February 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Ginsenoside

Ginsenoside :

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

Dietary Supplement: Ginsenoside
3.0 g/ d for 28 days
Other Name: Ginseng fill
Placebo Comparator: Dietary fiber fill
Dietary fiber fill manufactured to mimic Ginsenoside tablet
Dietary Supplement: Dietary fiber fill
3g/day, 28days



Primary Outcome Measures :
  1. Change from baseline in metabolic syndrome profile at week 4 [ Time Frame: Baseline and 4 weeks from intake of Ginsenoside ]
    Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight


Secondary Outcome Measures :
  1. Change from baseline in hormones at week 4. [ Time Frame: Initial and 4 weeks later ]
    insulin ,cortisol, testosterone, somatomedin-c and DHEAS


Other Outcome Measures:
  1. Mitochondria DNA copy number [ Time Frame: initial and 4 weeks later ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • metabolic syndrome

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034136


Contacts
Contact: DH Jung, MPH +82) 10-4204-8998 balsan2@empas.com
Contact: YJ Lee, Ph.D +82) 3015-2011 ykyjhome@yuhs.ac

Locations
Korea, Republic of
Bundang CHA Hospital Not yet recruiting
Seoul, Kyeonggi-do, Korea, Republic of
Contact: HG Park, PhD       irb@chamc.co.kr   
Principal Investigator: DH Jung, MPH         
Sponsors and Collaborators
CHA University
The Korean Society of Ginseng
Investigators
Principal Investigator: DH Jung, MPH.M.D. Cha Medical University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dong-Hyuk Jung, Assistant professor, Family medicine, CHA University
ClinicalTrials.gov Identifier: NCT02034136     History of Changes
Other Study ID Numbers: DH-13722
BD2013-104 ( Other Identifier: Cha medical university IRB )
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases