Ginsenoside Improve Metabolic Syndrome

• ClinicalTrials.gov Identifier: NCT02034136
• Recruitment Status: Unknown
• First Posted: January 13, 2014
• Last Update Posted: January 13, 2014
• Sponsor: CHA University
• Collaborator: The Korean Society of Ginseng
• Information provided by (Responsible Party): Dong-Hyuk Jung, CHA University

Tracking Information

• First Submitted Date: July 21, 2013
• First Posted Date: January 13, 2014
• Last Update Posted Date: January 13, 2014
• Study Start Date: February 2014
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2014)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 10, 2014)

Change from baseline in hormones at week 4. [ Time Frame: Initial and 4 weeks later ]

insulin ,cortisol, testosterone, somatomedin-c and DHEAS

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: January 10, 2014): Mitochondria DNA copy number [ Time Frame: initial and 4 weeks later ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

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

Brief Summary

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

Randomized Control Trial.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Metabolic Syndrome

Intervention

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

Study Arms

• Experimental: Ginsenoside

  Ginsenoside :

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

  Intervention: Dietary Supplement: Ginsenoside
• Placebo Comparator: Dietary fiber fill
  Dietary fiber fill manufactured to mimic Ginsenoside tablet
  Intervention: Dietary Supplement: Dietary fiber fill

Publications *

• 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.
• 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.
• 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.
• 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.
• Jung DH, Lee YJ, Kim CB, Kim JY, Shin SH, Park JK. Effects of ginseng on peripheral blood mitochondrial DNA copy number and hormones in men with metabolic syndrome: A randomized clinical and pilot study. Complement Ther Med. 2016 Feb;24:40-6. doi: 10.1016/j.ctim.2015.12.001. Epub 2015 Dec 4.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 10, 2014): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• metabolic syndrome

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02034136
• Other Study ID Numbers: DH-13722; BD2013-104 ( Other Identifier: Cha medical university IRB )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dong-Hyuk Jung, CHA University
• Study Sponsor: CHA University
• Collaborators: The Korean Society of Ginseng

Investigators

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

• PRS Account: CHA University
• Verification Date: January 2014