Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

Study Overview
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Brief Summary
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This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.

Detailed Description
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This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract 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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A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

Conditions
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Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Hydrolysed Red Ginseng Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19-80 years with fasting glucose 100-140 mg/dL Exclusion Criteria: Weight less than 48 kg or weight decreased by more than 10% within past 3 months Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc. Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months Blood sugar improvement or healthy functional food within past 1 month Under antipsychotic medication therapy within past 2 months History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test by show the following results aspartate aminotransferase, alanine aminotransferase > Reference range 3 times upper limit Serum Creatinine > 2.0 mg/dl Pregnancy or breast feeding If a woman of childbearing doesn't accept the implementation of appropriate contraception Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Hydrolysed red ginseng extract<br>Hydrolysed red ginseng extract 2.4g/day for 12 weeks | Dietary Supplement: Hydrolysed Red Ginseng Extract<br>* Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks | Dietary Supplement: Placebo<br>* Placebo for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood glucose | Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood insulin | Changes of blood insulin during OGTT were assessed before and after the intervention. | 12 weeks | 
| Changes of area under the curve of Glucose and Insulin | Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention. | 12 weeks | 
| Changes of Homeostatic model assessment-insulin resistance | Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention. | 12 weeks | 
| Changes of Homeostatic model assessment-beta-cell | Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention | 12 weeks | 
| Changes of HbA1c | Changes of HbA1c(%) were assessed before and after the intervention | 12 weeks | 
| Changes of C-peptide | Changes of C-peptide(ng/ml) were assessed before and after the intervention. | 12 weeks | 
| Changes of lipid profile | Changes of lipid profile were assessed before and after the intervention. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrolysed red ginseng extract, Glucose, Clinical Trial