Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract
1 other identifier
interventional
20
1 country
1
Brief Summary
This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2009
Shorter than P25 for not_applicable
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
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedMarch 15, 2016
March 1, 2016
6 months
May 13, 2013
March 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of blood glucose during OGTT(oral glucose tolerance test)
Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.
8 weeks
Secondary Outcomes (2)
Changes of blood insulin during OGTT.
8 weeks
Changes of glycated albumin, fructosamine, and lipid profile
8 weeks
Study Arms (2)
HGE(hydrolyzed ginseng extract)
EXPERIMENTALHGE capsules(2cap/d, 960mg/d) for 8 weeks.
Placebo
PLACEBO COMPARATORPlacebo for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Age 20-70 years with fasting glucose 100\~126 mg/dL
You may not qualify if:
- Abnormal lipid profile values
- Acute/chronic inflammation
- Treated with corticosteroid within past 4 weeks
- Cardiovascular disease
- Allergic or hypersensitive to any of the ingredients in the test products
- History of disease that could interfere with the test products or impede their absorption
- Participation in any other clinical trials within past 2 months
- Renal disease
- Abnormal hepatic function
- Under hypolipidemic drugs therapy within past 3 months
- Under antipsychotic drugs therapy within past 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- History of alcohol or substance abuse
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- 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
May 13, 2013
First Posted
May 15, 2013
Study Start
June 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 15, 2016
Record last verified: 2016-03