Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

Study Overview
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Brief Summary
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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
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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.

Official Title
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An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract

Conditions
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Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: HGE (hydrolyzed ginseng extract)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HGE(hydrolyzed ginseng extract)<br>HGE capsules(2cap/d, 960mg/d) for 8 weeks. | Dietary Supplement: HGE (hydrolyzed ginseng extract)<br> <br> |
| Placebo Comparator: Placebo<br>Placebo for 8 weeks | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood insulin during OGTT. | Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention. | 8 weeks | 
| Changes of glycated albumin, fructosamine, and lipid profile | Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HGE, impaired fasting glucose, clinical trial