Clinical trial NCT03258229: Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: Angelica gigas N. extract
Glucose
Clinical Trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2×2 cross-over Assignment
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes of blood glucose during OGTT (oral glucose tolerance test)
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of blood insulin during OGTT
timeFrame: 8 weeks
measure: Changes of Homeostatic model assessment-insulin resistance
timeFrame: 8 weeks
measure: Changes of Homeostatic model assessment-beta-cell
timeFrame: 8 weeks
measure: Changes of HbA1c
timeFrame: 8 weeks
measure: Changes of Adiponectin, Leptin
timeFrame: 8 weeks
measure: Changes of lipid profile
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: