Korean Red Ginseng and Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: starch; Dietary Supplement: Korean red ginseng

• Registration Number: NCT00976274
• Lead Sponsor: The Korean Society of Ginseng

Brief Summary

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

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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-01-19
• Results First Submitted QC: 2012-01-19
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-23
• Results First Posted: 2012-02-24
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
starch capsule	starch	-
Korea red ginseng	Korean red ginseng	-

Primary Outcome Measures

Name	Time	Method
Change in the Pre- and Post-treatment Systolic Blood Pressure	baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)	baseline and 12 weeks

Trial Locations

Locations (1)

Yonsei Univeristy College of Medicine, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of