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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01826409
First Posted: April 8, 2013
Last Update Posted: August 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Soo-Wan Chae, Chonbuk National University Hospital:

Primary Outcome Measures:
  • Glucose profiles during meal tolerance test [ Time Frame: 4 weeks ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 4, 2013
First Posted: April 8, 2013
Last Update Posted: August 29, 2013
Last Verified: August 2013

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