NCT02034136

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 13, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

July 21, 2013

Last Update Submit

January 10, 2014

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change from baseline in hormones at week 4.

    Initial and 4 weeks later

Other Outcomes (1)

  • Mitochondria DNA copy number

    initial and 4 weeks later

Study Arms (2)

Ginsenoside

EXPERIMENTAL

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

Dietary Supplement: Ginsenoside

Dietary fiber fill

PLACEBO COMPARATOR

Dietary fiber fill manufactured to mimic Ginsenoside tablet

Dietary Supplement: Dietary fiber fill

Interventions

GinsenosideDIETARY_SUPPLEMENT

3.0 g/ d for 28 days

Also known as: Ginseng fill
Ginsenoside
Dietary fiber fillDIETARY_SUPPLEMENT

3g/day, 28days

Dietary fiber fill

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • metabolic syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundang CHA Hospital

Seoul, Kyeonggi-do, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 22916320BACKGROUND

  • 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.

    PMID: 18339495BACKGROUND

  • 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.

    PMID: 23089630BACKGROUND

  • 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. doi: 10.1007/BF02977653.

    PMID: 17615678BACKGROUND

  • 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.

    PMID: 22589267BACKGROUND

  • 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.

    PMID: 26860800DERIVED

Related Links

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Ginsenosides

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TriterpenesTerpenesHydrocarbonsOrganic ChemicalsSaponinsGlycosidesCarbohydrates

Study Officials

  • DH Jung, MPH.M.D.

    Cha Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DH Jung, MPH

CONTACT

+82) 10-4204-8998balsan2@empas.com

YJ Lee, Ph.D

CONTACT

+82) 3015-2011ykyjhome@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Family medicine

Study Record Dates

First Submitted

July 21, 2013

First Posted

January 13, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

January 13, 2014

Record last verified: 2014-01

Locations

KR(1)