Ginsenoside Improve Metabolic Syndrome

January 10, 2014 updated by: Dong-Hyuk Jung, CHA University

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

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

Randomized Control Trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Kyeonggi-do
      • Seoul, Kyeonggi-do, Korea, Republic of
        • Bundang CHA Hospital
        • Contact:
        • Principal Investigator:
          • DH Jung, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • metabolic syndrome

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Ginseng fill
Placebo Comparator: Dietary fiber fill
Dietary fiber fill manufactured to mimic Ginsenoside tablet
Dietary supplement: Dietary fiber fill
3g/day, 28days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 4 weeks from intake of Ginsenoside

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in hormones at week 4.
Time Frame: Initial and 4 weeks later
insulin ,cortisol, testosterone, somatomedin-c and DHEAS
Initial and 4 weeks later

Other Outcome Measures

Outcome Measure
Time Frame
Mitochondria DNA copy number
Time Frame: initial and 4 weeks later
initial and 4 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA University

Collaborators

The Korean Society of Ginseng

Investigators

  • Principal Investigator: DH Jung, MPH.M.D., Cha Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 21, 2013

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DH-13722
  • BD2013-104 (Other Identifier: Cha medical university IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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