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临床试验/NCT02034136
NCT02034136Unknown不适用

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

CHA University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Change from baseline in metabolic syndrome profile at week 4

研究概览

简要总结

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

Randomized Control Trial.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •metabolic syndrome

排除标准

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

研究组 & 干预措施

Dietary fiber fill

Placebo Comparator

Dietary fiber fill manufactured to mimic Ginsenoside tablet

干预措施: Dietary fiber fill (Dietary Supplement)

Ginsenoside

Experimental

Ginsenoside :

Intervention : ginsenoside, 3 gram / day, for 28 days in intervention group

干预措施: Ginsenoside (Dietary Supplement)

结局指标

主要结局

Change from baseline in metabolic syndrome profile at week 4

时间窗: Baseline and 4 weeks from intake of Ginsenoside

Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight

次要结局

  • Change from baseline in hormones at week 4.(Initial and 4 weeks later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong-Hyuk Jung

Assistant professor, Family medicine

CHA University

研究点 (1)

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