Ginsenoside Improve Metabolic Syndrome

Not Applicable

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Ginsenoside; Dietary Supplement: Dietary fiber fill

• Registration Number: NCT02034136
• Lead Sponsor: CHA University

Brief Summary

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

Randomized Control Trial.

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 Timeline

• Study First Submitted: 2013-07-21
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-10
• Last Update Submitted: 2014-01-10
• Study First Posted: 2014-01-13
• Last Update Posted: 2014-01-13
• Study Start: 2014-02
• Primary Completion: 2014-09
• Study Completion: 2014-12

Recruitment & Eligibility

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

Inclusion Criteria

• metabolic syndrome

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginsenoside	Ginsenoside	Ginsenoside : Intervention : ginsenoside, 3 gram / day, for 28 days in intervention group
Dietary fiber fill	Dietary fiber fill	Dietary fiber fill manufactured to mimic Ginsenoside tablet

Primary Outcome Measures

Name	Time	Method
Change from baseline in metabolic syndrome profile at week 4	Baseline and 4 weeks from intake of Ginsenoside	Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight

Secondary Outcome Measures

Name	Time	Method
Change from baseline in hormones at week 4.	Initial and 4 weeks later	insulin ,cortisol, testosterone, somatomedin-c and DHEAS

Trial Locations

Locations (1)

Bundang CHA Hospital; 🇰🇷 Seoul, Kyeonggi-do, Korea, Republic of