Ginsenoside Improve Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02034136
• Other study ID #: DH-13722
• Secondary ID: BD2013-104
• Status: Not yet recruiting
• Phase: N/A
• First received: July 21, 2013
• Last updated: January 10, 2014
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: CHA University
• Contact: DH Jung, MPH
• Phone: +82) 10-4204-8998
• Email: balsan2[@]empas.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Randomized Control Trial.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• metabolic syndrome

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Ginsenoside
3.0 g/ d for 28 days
• Dietary fiber fill
3g/day, 28days

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA Hospital	Seoul	Kyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
CHA University	The Korean Society of Ginseng

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Kim JH, Lee DC. Mitochondrial DNA copy number in peripheral blood is associated with femoral neck bone mineral density in postmenopausal women. J Rheumatol. 2012 Jul;39(7):1465-72. doi: 10.3899/jrheum.111444. Epub 2012 May 15. — View Citation

Lamers F, Vogelzangs N, Merikangas KR, de Jonge P, Beekman AT, Penninx BW. Evidence for a differential role of HPA-axis function, inflammation and metabolic syndrome in melancholic versus atypical depression. Mol Psychiatry. 2013 Jun;18(6):692-9. doi: 10.1038/mp.2012.144. Epub 2012 Oct 23. — View Citation

Park BJ, Lee YJ, Lee HR, Jung DH, Na HY, Kim HB, Shim JY. Effects of Korean Red Ginseng on Cardiovascular Risks in Subjects with Metabolic Syndrome: a Double-blind Randomized Controlled Study. Korean J Fam Med. 2012 Jul;33(4):190-6. doi: 10.4082/kjfm.2012.33.4.190. Epub 2012 Jul 25. — View Citation

Rasheed N, Tyagi E, Ahmad A, Siripurapu KB, Lahiri S, Shukla R, Palit G. Involvement of monoamines and proinflammatory cytokines in mediating the anti-stress effects of Panax quinquefolium. J Ethnopharmacol. 2008 May 8;117(2):257-62. doi: 10.1016/j.jep.2008.01.035. Epub 2008 Feb 8. — View Citation

Yun SN, Ko SK, Lee KH, Chung SH. Vinegar-processed ginseng radix improves metabolic syndrome induced by a high fat diet in ICR mice. Arch Pharm Res. 2007 May;30(5):587-95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mitochondria DNA copy number		initial and 4 weeks later	Yes
Primary	Change from baseline in metabolic syndrome profile at week 4	Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight	Baseline and 4 weeks from intake of Ginsenoside	Yes
Secondary	Change from baseline in hormones at week 4.	insulin ,cortisol, testosterone, somatomedin-c and DHEAS	Initial and 4 weeks later	Yes

External Links

•   The goal of Korean ginsengsociety is to help elevate the level of ginseng science in both theory and practice by providing technical information to the ginseng industry, providing ginseng-related education to the community.