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Korean Red Ginseng and Metabolic Syndrome

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StatusCompleted
Sponsors
The Korean Society of Ginseng

Keywords

Abstract

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.

Description

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

Dates

Last Verified: 01/31/2012
First Submitted: 09/10/2009
Estimated Enrollment Submitted: 09/10/2009
First Posted: 09/13/2009
Last Update Submitted: 02/22/2012
Last Update Posted: 02/26/2012
Date of first submitted results: 01/18/2012
Date of first submitted QC results: 01/18/2012
Date of first posted results: 02/23/2012
Actual Study Start Date: 07/31/2009
Estimated Primary Completion Date: 12/31/2010
Estimated Study Completion Date: 12/31/2010

Condition or disease

Metabolic Syndrome

Intervention/treatment

Dietary Supplement: Korea red ginseng

Dietary Supplement: starch capsule

Phase

-

Arm Groups

ArmIntervention/treatment
Placebo Comparator: starch capsule
Dietary Supplement: starch capsule
5 capsules three times everyday for 12 weeks
Experimental: Korea red ginseng
Dietary Supplement: Korea red ginseng
5 capsules (300 mg/capsule) three times everyday for 12 weeks

Eligibility Criteria

Ages Eligible for Study 20 Years To 20 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

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

Outcome

Primary Outcome Measures

1. Change in the Pre- and Post-treatment Systolic Blood Pressure [baseline and 12 weeks]

Secondary Outcome Measures

1. Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) [baseline and 12 weeks]

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