Ginsenoside Improve Metabolic Syndrome

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by CHA University
Sponsor:
Collaborator:
The Korean Society of Ginseng
Information provided by (Responsible Party):
Dong-Hyuk Jung, CHA University
ClinicalTrials.gov Identifier:
NCT02034136
First received: July 21, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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

Randomized Control Trial.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: Ginsenoside
Dietary Supplement: Dietary fiber fill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by CHA University:

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


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


Other Outcome Measures:
  • Mitochondria DNA copy number [ Time Frame: initial and 4 weeks later ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Dietary fiber fill

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • metabolic syndrome

Exclusion Criteria:

  • Taking drug for lipid-lowering, BP control and anti-diabetic.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
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
Study First Received: July 21, 2013
Last Updated: January 10, 2014
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014