Ginsenoside Improve Metabolic Syndrome

• Sponsor: CHA University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02034136
• Collaborator: The Korean Society of Ginseng (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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: Feb 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ginsenoside Ginsenoside : Intervention : ginsenoside, 3 gram / day, for 28 days in intervention group	Dietary Supplement: Ginsenoside; 3.0 g/ d for 28 days; Other Names: Ginseng fill
Placebo Comparator: Dietary fiber fill Dietary fiber fill manufactured to mimic Ginsenoside tablet	Dietary Supplement: Dietary fiber fill; 3g/day, 28days

Outcome Measures

Primary Outcome Measures

1. 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

1. Change from baseline in hormones at week 4. [Initial and 4 weeks later]

   insulin ,cortisol, testosterone, somatomedin-c and DHEAS

Other Outcome Measures

1. Mitochondria DNA copy number [initial and 4 weeks later]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• metabolic syndrome

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bundang CHA Hospital	Seoul	Kyeonggi-do	Korea, Republic of

Sponsors and Collaborators

• CHA University
• The Korean Society of Ginseng

Investigators

• Principal Investigator: DH Jung, MPH.M.D., Cha Medical University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Dong-Hyuk Jung, Assistant professor, Family medicine, CHA University
• ClinicalTrials.gov Identifier: NCT02034136
• Other Study ID Numbers: DH-13722; BD2013-104
• First Posted: Jan 13, 2014
• Last Update Posted: Jan 13, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Jan 13, 2014