Efficacy and Safety of Angelica Gigas N. 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 Angelica gigas N. extract on improvement of Hyperglycemia .

Detailed Description
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This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. 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 8-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia

Conditions
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Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Angelica gigas N. extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl Exclusion Criteria: Weight less than 48 kg or weight decreased by more than 10% within past 3 months Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks Treated with corticosteroid within past 4 weeks Severe cardiovascular disease(Mvocardial infarction, Stroke, etc) Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc) Rheumatoid arthritis, Autoimmune disease Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary 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 Under antipsychotic drugs 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 upper limit treble Serum Creatinine > 2.0 mg/dl Pregnancy or breast feeding Not Contraception(except: Surgery for female infertility)

Ages Eligible for Study
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Minimum Age: 20 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: Crossover Assignment
Interventional Model Description: 2×2 cross-over Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angelica gigas N. extract<br>capsules(2cap/d, 1,000mg/d) for 8 weeks. | Dietary Supplement: Angelica gigas N. extract<br>* capsules(2cap/d, 1,000mg/d) for 8 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo for 8 weeks | Dietary Supplement: Placebo<br>* Placebo for 8 weeks<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 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 and after the intervention. | 8 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 | 8 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 | 8 weeks | 
| Changes of HbA1c | Changes of HbA1c(%) were assessed before and after the intervention | 8 weeks | 
| Changes of Adiponectin, Leptin | Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention | 8 weeks | 
| Changes of lipid profile | Changes of lipid profile were assessed before 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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Angelica gigas N. extract, Glucose, Clinical Trial