Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

Not Applicable

• Conditions: Hyperglycemia
• Interventions: Dietary Supplement: Hydrolysed Red Ginseng Extract; Dietary Supplement: Placebo

• Registration Number: NCT03775733
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2018-09-07
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-14
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrolysed red ginseng extract	Hydrolysed Red Ginseng Extract	Hydrolysed red ginseng extract 2.4g/day for 12 weeks
Placebo	Placebo	Placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes of blood glucose	12 weeks	Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.

Secondary Outcome Measures

Name	Time	Method
Changes of blood insulin	12 weeks	Changes of blood insulin during OGTT were assessed before and after the intervention.
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 HbA1c	12 weeks	Changes of HbA1c(%) 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.

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of