Back to resultsHypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes
Primary Purpose
Impaired Glucose or Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fermented Red Ginseng
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Impaired Glucose or Type 2 Diabetes
Eligibility Criteria
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,
Sites / Locations
- Clincial Trial Center for Functional Foods
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fermented red ginseng
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Glucose profiles during meal tolerance test
Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention
Secondary Outcome Measures
Change in lipid profiles
Change in lipid profiles were assessed before(baseline) and after the intervention
Full Information
NCT ID
NCT01826409
First Posted
April 4, 2013
Last Updated
August 28, 2013
Sponsor
Chonbuk National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01826409
Brief Title
Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
undefined (undefined)
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 fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose or Type 2 Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fermented red ginseng
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermented Red Ginseng
Intervention Description
Fermented red ginseng 2.7g/day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo 2.7g/day for 4 weeks
Primary Outcome Measure Information:
Title
Glucose profiles during meal tolerance test
Description
Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in lipid profiles
Description
Change in lipid profiles were assessed before(baseline) and after the intervention
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Sun Park, MD., PhD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clincial Trial Center for Functional Foods
City
Jeonju
State/Province
Jeollabok-do
ZIP/Postal Code
560-822
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25015735
Citation
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.
Results Reference
derived
Learn more about this trial
Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes
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