Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ginsenoside Improve Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 21, 2013
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date January 13, 2014
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Change from baseline in hormones at week 4. [ Time Frame: Initial and 4 weeks later ]
insulin ,cortisol, testosterone, somatomedin-c and DHEAS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2014)
Mitochondria DNA copy number [ Time Frame: initial and 4 weeks later ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ginsenoside Improve Metabolic Syndrome
Official Title  ICMJE Effects of Ginsenoside Supplementation on Insulin Resistance and Cardiometabolic Risk Factors in Men With Metabolic Syndrome: a Randomized Controlled Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Ginsenoside
    3.0 g/ d for 28 days
    Other Name: Ginseng fill
  • Dietary Supplement: Dietary fiber fill
    3g/day, 28days
Study Arms  ICMJE
  • Experimental: Ginsenoside

    Ginsenoside :

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

    Intervention: Dietary Supplement: Ginsenoside
  • Placebo Comparator: Dietary fiber fill
    Dietary fiber fill manufactured to mimic Ginsenoside tablet
    Intervention: Dietary Supplement: Dietary fiber fill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • metabolic syndrome

Exclusion Criteria:

  • Taking drug for lipid-lowering, BP control and anti-diabetic.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034136
Other Study ID Numbers  ICMJE DH-13722
BD2013-104 ( Other Identifier: Cha medical university IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-Hyuk Jung, CHA University
Study Sponsor  ICMJE CHA University
Collaborators  ICMJE The Korean Society of Ginseng
Investigators  ICMJE
Principal Investigator: DH Jung, MPH.M.D. Cha Medical University
PRS Account CHA University
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP