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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
April 4, 2013
April 8, 2013
August 29, 2013
March 2008
September 2009   (Final data collection date for primary outcome measure)
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
Glusoe 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 intervenstion
Complete list of historical versions of study NCT01826409 on ClinicalTrials.gov Archive Site
Change in lipid profiles [ Time Frame: 4 weeks ]
Change in lipid profiles were assessed before(baseline) and after the intervention
Change of lipide profiles [ Time Frame: 4 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Oh MR, Park SH, Kim SY, Back HI, Kim MG, Jeon JY, Ha KC, Na WT, Cha YS, Park BH, Park TS, Chae SW. Postprandial glucose-lowering effects of fermented red ginseng in subjects with impaired fasting glucose or type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2014 Jul 11;14:237. doi: 10.1186/1472-6882-14-237.

*   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,
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01826409
WKP-FG7070-001
Yes
Not Provided
Not Provided
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