Ginsenoside Improve Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT02034136|
Recruitment Status : Unknown
Verified January 2014 by Dong-Hyuk Jung, CHA University.
Recruitment status was: Not yet recruiting
First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters such as cholesterol, blood pressure and glucose.
Randomized Control Trial.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Dietary Supplement: Ginsenoside Dietary Supplement: Dietary fiber fill||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Ginsenoside Supplementation on Insulin Resistance and Cardiometabolic Risk Factors in Men With Metabolic Syndrome: a Randomized Controlled Trial.|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2014|
Intervention : ginsenoside, 3 gram / day, for 28 days in intervention group
Dietary Supplement: Ginsenoside
3.0 g/ d for 28 days
Other Name: Ginseng fill
Placebo Comparator: Dietary fiber fill
Dietary fiber fill manufactured to mimic Ginsenoside tablet
Dietary Supplement: Dietary fiber fill
- Change from baseline in metabolic syndrome profile at week 4 [ Time Frame: Baseline and 4 weeks from intake of Ginsenoside ]Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight
- Change from baseline in hormones at week 4. [ Time Frame: Initial and 4 weeks later ]insulin ,cortisol, testosterone, somatomedin-c and DHEAS
- Mitochondria DNA copy number [ Time Frame: initial and 4 weeks later ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034136
|Contact: DH Jung, MPH||+82) firstname.lastname@example.org|
|Contact: YJ Lee, Ph.D||+82) email@example.com|
|Korea, Republic of|
|Bundang CHA Hospital||Not yet recruiting|
|Seoul, Kyeonggi-do, Korea, Republic of|
|Contact: HG Park, PhD firstname.lastname@example.org|
|Principal Investigator: DH Jung, MPH|
|Principal Investigator:||DH Jung, MPH.M.D.||Cha Medical University|