Ginsenoside Improve Metabolic Syndrome
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|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|