Hyperglycemia
Conditions
Keywords
Angelica gigas N. extract, Glucose, Clinical Trial
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.
Interventions
DIETARY_SUPPLEMENTAngelica gigas N. extract
capsules(2cap/d, 1,000mg/d) for 8 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo for 8 weeks
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
2×2 cross-over Assignment
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 blood insulin during OGTT | 8 weeks | Changes of blood insulin during OGTT 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 HbA1c | 8 weeks | Changes of HbA1c(%) were assessed before and after the intervention |
Countries
South Korea
Outcome results
None listed