Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedAugust 29, 2013
August 1, 2013
1.5 years
April 4, 2013
August 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose profiles during meal tolerance test
Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention
4 weeks
Secondary Outcomes (1)
Change in lipid profiles
4 weeks
Study Arms (2)
Fermented red ginseng
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Fermented red ginseng 2.7g/day for 4 weeks
Eligibility Criteria
You may qualify if:
- Age 20-75 years with fasting glucose 100\~140 mg/dL at least two of the following
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clincial Trial Center for Functional Foods
Jeonju, Jeollabok-do, 560-822, South Korea
Related Publications (1)
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.
PMID: 25015735DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae Sun Park, MD., PhD
Chonbuk National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
April 4, 2013
First Posted
April 8, 2013
Study Start
March 1, 2008
Primary Completion
September 1, 2009
Last Updated
August 29, 2013
Record last verified: 2013-08