Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
First received: April 4, 2013
Last updated: August 28, 2013
Last verified: August 2013
This study was conducted to investigate the effects of daily supplementation of fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.

Condition Intervention Phase
Impaired Glucose or Type 2 Diabetes
Dietary Supplement: Fermented Red Ginseng
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Glucose profiles during meal tolerance test [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention

Secondary Outcome Measures:
  • Change in lipid profiles [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Change in lipid profiles were assessed before(baseline) and after the intervention

Enrollment: 42
Study Start Date: March 2008
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fermented red ginseng Dietary Supplement: Fermented Red Ginseng
Fermented red ginseng 2.7g/day for 4 weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo 2.7g/day for 4 weeks

Detailed Description:
This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance test were assessed before and after the intervention.

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 20-75 years with fasting glucose 100~140 mg/dL at least two of the following

Exclusion Criteria:

  • Lipid metabolic disorder
  • Acute or chronic inflammatory disease
  • Taking medication of corticosteroid within 4 weeks of the study
  • Cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker)
  • Allergic or hypersensitive to any of the ingredients in the test products
  • Participation in other clinical trials within 2 months
  • Abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome)
  • Taking medication of lipid phosphates within 3 months of the study etc,
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01826409

Korea, Republic of
Clincial Trial Center for Functional Foods
Jeonju, Jeollabok-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Principal Investigator: Tae Sun Park, MD., PhD Chonbuk National University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01826409     History of Changes
Other Study ID Numbers: WKP-FG7070-001 
Study First Received: April 4, 2013
Last Updated: August 28, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2016