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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01826409
First received: April 4, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.

  Eligibility

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

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,
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01826409

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

No publications provided by Chonbuk National University Hospital

Additional 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014