Ginsenoside Improve Metabolic Syndrome

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

Detailed Description
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Ginsenoside
* Dietary Supplement: Dietary fiber fill


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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginsenoside<br>Ginsenoside : Intervention : ginsenoside, 3 gram / day, for 28 days in intervention group | Dietary Supplement: Ginsenoside<br>* 3.0 g/ d for 28 days<br>* Other names: Ginseng fill;|
| Placebo Comparator: Dietary fiber fill<br>Dietary fiber fill manufactured to mimic Ginsenoside tablet | Dietary Supplement: Dietary fiber fill<br>* 3g/day, 28days<br>|

What is the study measuring?
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Primary Outcome Measures

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