Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

Hyperglycemia Clinical Trial

Official title:

An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854164
• Other study ID #: Ilhwa-FG-001
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: March 13, 2016
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2016
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).

Description:

This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 20-70 years with fasting glucose 100~126 mg/dL

Exclusion Criteria:

• Abnormal lipid profile values

• Acute/chronic inflammation

• Treated with corticosteroid within past 4 weeks

• Cardiovascular 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

• Participation in any other clinical trials within past 2 months

• Renal disease

• Abnormal hepatic function

• Under hypolipidemic drugs therapy within past 3 months

• Under antipsychotic drugs therapy within past 2 months

• Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

• History of alcohol or substance abuse

• Pregnancy or breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Dietary Supplement:
• HGE (hydrolyzed ginseng extract)

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods, Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of blood glucose during OGTT(oral glucose tolerance test)	Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.	8 weeks	Yes
Secondary	Changes of blood insulin during OGTT.	Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.	8 weeks	Yes
Secondary	Changes of glycated albumin, fructosamine, and lipid profile	Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention	8 weeks	Yes