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

April 4, 2013
August 28, 2013
March 2008
September 2009   (final data collection date for primary outcome measure)
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
Glusoe 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 intervenstion
Complete list of historical versions of study NCT01826409 on ClinicalTrials.gov Archive Site
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
Change of lipide profiles [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Change of lipide profiles were assessed before(baseline) and after the intervenstion
Not Provided
Not Provided
 
Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes
Not Provided

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Impaired Glucose or Type 2 Diabetes
  • Dietary Supplement: Fermented Red Ginseng
    Fermented red ginseng 2.7g/day for 4 weeks
  • Dietary Supplement: Placebo
    Placebo 2.7g/day for 4 weeks
  • Experimental: Fermented red ginseng
    Intervention: Dietary Supplement: Fermented Red Ginseng
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
September 2009   (final data collection date for primary outcome measure)

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,
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01826409
WKP-FG7070-001
Yes
Soo-Wan Chae, Chonbuk National University Hospital
Chonbuk National University Hospital
Not Provided
Principal Investigator: Tae Sun Park, MD., PhD Chonbuk National University Hospital
Chonbuk National University Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP