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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes of blood glucose during OGTT (oral glucose tolerance test)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Placebo
Placebo for 8 weeks
Intervention: Placebo (Dietary Supplement)
Angelica gigas N. extract
capsules(2cap/d, 1,000mg/d) for 8 weeks.
Intervention: Angelica gigas N. extract (Dietary Supplement)
Outcomes
Primary Outcomes
Changes of blood glucose during OGTT (oral glucose tolerance test)
Time Frame: 8 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
Secondary Outcomes
- Changes of HbA1c(8 weeks)
- Changes of Homeostatic model assessment-insulin resistance(8 weeks)
- Changes of Homeostatic model assessment-beta-cell(8 weeks)
- Changes of Adiponectin, Leptin(8 weeks)
- Changes of lipid profile(8 weeks)
- Changes of blood insulin during OGTT(8 weeks)
Investigators
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital