Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
- Conditions
- Hyperglycemia
- Interventions
- Dietary Supplement: Angelica gigas N. extractDietary Supplement: Placebo
- Registration Number
- NCT03258229
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Hyperglycemia .
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl
-
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
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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
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History of alcohol or substance abuse
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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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Angelica gigas N. extract Angelica gigas N. extract capsules(2cap/d, 1,000mg/d) for 8 weeks. Placebo Placebo Placebo for 8 weeks
- Primary Outcome Measures
Name Time Method Changes of blood glucose during OGTT (oral glucose tolerance test) 8 weeks Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
- Secondary Outcome Measures
Name Time Method Changes of HbA1c 8 weeks Changes of HbA1c(%) were assessed before and after the intervention
Changes of Homeostatic model assessment-insulin resistance 8 weeks Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention
Changes of Homeostatic model assessment-beta-cell 8 weeks Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
Changes of Adiponectin, Leptin 8 weeks Changes of Adiponectin and Leptin(ng/ml) were assessed before and after the intervention
Changes of lipid profile 8 weeks Changes of lipid profile were assessed before and after the intervention
Changes of blood insulin during OGTT 8 weeks Changes of blood insulin during OGTT were assessed before and after the intervention.
Trial Locations
- Locations (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of