Clinical trial NCT03775733: Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia
Keywords: Hydrolysed red ginseng extract
Glucose
Clinical Trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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.

Primary outcomes:
measure: Changes of blood glucose
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of blood insulin
timeFrame: 12 weeks
measure: Changes of area under the curve of Glucose and Insulin
timeFrame: 12 weeks
measure: Changes of Homeostatic model assessment-insulin resistance
timeFrame: 12 weeks
measure: Changes of Homeostatic model assessment-beta-cell
timeFrame: 12 weeks
measure: Changes of HbA1c
timeFrame: 12 weeks
measure: Changes of C-peptide
timeFrame: 12 weeks
measure: Changes of lipid profile
timeFrame: 12 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: