Back to resultsEfficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
Primary Purpose
Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HGE (hydrolyzed ginseng extract)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia focused on measuring HGE, impaired fasting glucose, clinical trial
Eligibility Criteria
Inclusion Criteria:
- Age 20-70 years with fasting glucose 100~126 mg/dL
Exclusion Criteria:
- 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
Sites / Locations
- Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HGE(hydrolyzed ginseng extract)
Placebo
Arm Description
HGE capsules(2cap/d, 960mg/d) for 8 weeks.
Placebo for 8 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes of blood insulin during OGTT.
Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.
Changes of glycated albumin, fructosamine, and lipid profile
Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention
Full Information
NCT ID
NCT01854164
First Posted
May 13, 2013
Last Updated
March 13, 2016
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01854164
Brief Title
Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
Official Title
An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
HGE, impaired fasting glucose, clinical trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HGE(hydrolyzed ginseng extract)
Arm Type
Experimental
Arm Description
HGE capsules(2cap/d, 960mg/d) for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
HGE (hydrolyzed ginseng extract)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Changes of blood glucose during OGTT(oral glucose tolerance test)
Description
Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes of blood insulin during OGTT.
Description
Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.
Time Frame
8 weeks
Title
Changes of glycated albumin, fructosamine, and lipid profile
Description
Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 20-70 years with fasting glucose 100~126 mg/dL
Exclusion Criteria:
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
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
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