NCT03775733
Unknown
Not Applicable
A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
ConditionsHyperglycemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperglycemia
- Sponsor
- Chonbuk National University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes of blood glucose
- Last Updated
- 5 years ago
Overview
Brief Summary
This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.
Detailed Description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
Investigators
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 19-80 years with fasting glucose 100-140 mg/dL
Exclusion Criteria
- •Weight less than 48 kg or weight decreased by more than 10% within past 3 months
- •Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
- •Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
- •Blood sugar improvement or healthy functional food within past 1 month
- •Under antipsychotic medication 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 3 times upper limit
- •Serum Creatinine \> 2.0 mg/dl
Outcomes
Primary Outcomes
Changes of blood glucose
Time Frame: 12 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
Secondary Outcomes
- Changes of blood insulin(12 weeks)
- Changes of area under the curve of Glucose and Insulin(12 weeks)
- Changes of Homeostatic model assessment-insulin resistance(12 weeks)
- Changes of Homeostatic model assessment-beta-cell(12 weeks)
- Changes of HbA1c(12 weeks)
- Changes of C-peptide(12 weeks)
- Changes of lipid profile(12 weeks)
Study Sites (1)
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