Korean Red Ginseng and Metabolic Syndrome

Study Overview
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Brief Summary
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Five factor consisting of Metabolic syndrome is closely linked by insulin resistance. Until now, several studies have been performed about effects of Korea red ginseng on hypertension, diabetes, and hyperlipidemia, but not metabolic syndrome. The investigators hypothesize that Korean red ginseng could improve each constituents of metabolic syndrome, arterial stiffness, and inflammatory markers. The aim of this study is to determine effects of Korean red ginseng on cardiovascular risks in subjects with metabolic syndrome.

Detailed Description
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The details of study objective are followed by these: comparison of blood pressure before and after Korean red ginseng administration comparison of metabolic indicator before and after Korean red ginseng administration comparison of oxidative stress and inflammatory markers before and after Korean red ginseng administration comparison of arterial stiffness before and after Korean red ginseng administration

Official Title
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Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects With Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Korean red ginseng
* Dietary Supplement: starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:(three or more of following five factors) waist circumference(male: more than 90cm, female: more than 80cm) blood pressure(systolic: more than 130mmHg, diastolic: more than 85mmHg) fasting plasma glucose: more than 100mg/dL fasting triglycerides: more than 150mg/dL High-density lipoprotein(HDL)-cholesterol(male: less than 40mg/dL, female: less than 50mg/dL) Exclusion Criteria: (any one of following factors) uncontrolled blood pressure(systolic: more than 160mmHg, diastolic: more than 100mmHg) or subjects taking blood pressure lowering drug Type 2 diabetes patients or fasting plasma glucose more than 126mg/dL triglyceride more than 400mg/dL, total cholesterol more than 250mg/dL subjects taking antilipidemic drug past history of coronary heart disease or cerebrovascular disease

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: starch capsule<br> | Dietary Supplement: starch<br>* 5 capsules three times everyday for 12 weeks<br>* Other names: KGC1039015;|
| Experimental: Korea red ginseng<br> | Dietary Supplement: Korean red ginseng<br>* 5 capsules (300 mg/capsule) three times everyday for 12 weeks<br>* Other names: Korean Red Ginseng Powder Capsule, KGC1039012;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Pre- and Post-treatment Systolic Blood Pressure |  | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) |  | baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korean red ginseng, metabolic syndrome, blood pressure, arterial stiffness, inflammation, oxidative stress