Hyperglycemia
Conditions
Keywords
Hydrolysed red ginseng extract, Glucose, Clinical Trial
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.
Interventions
DIETARY_SUPPLEMENTHydrolysed Red Ginseng Extract
Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
Placebo for 12 weeks.
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
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 * Pregnancy or breast feeding * If a woman of childbearing doesn't accept the implementation of appropriate contraception * Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of blood glucose | 12 weeks | Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of area under the curve of Glucose and Insulin | 12 weeks | Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention. |
| Changes of Homeostatic model assessment-insulin resistance | 12 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 | 12 weeks | Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention |
| Changes of blood insulin | 12 weeks | Changes of blood insulin during OGTT were assessed before and after the intervention. |
| Changes of C-peptide | 12 weeks | Changes of C-peptide(ng/ml) were assessed before and after the intervention. |
| Changes of lipid profile | 12 weeks | Changes of lipid profile were assessed before and after the intervention. |
| Changes of HbA1c | 12 weeks | Changes of HbA1c(%) were assessed before and after the intervention |
Countries
South Korea
Outcome results
None listed