Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

Not Applicable

Completed

• Conditions: Hyperglycemia
• Interventions: Dietary Supplement: HGE (hydrolyzed ginseng extract); Dietary Supplement: Placebo

• Registration Number: NCT01854164
• Lead Sponsor: Chonbuk National University Hospital

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-15
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-13
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HGE(hydrolyzed ginseng extract)	HGE (hydrolyzed ginseng extract)	HGE capsules(2cap/d, 960mg/d) for 8 weeks.
Placebo	Placebo	Placebo for 8 weeks

Primary Outcome Measures

Name	Time	Method
Changes of blood glucose during OGTT(oral glucose tolerance test)	8 weeks	Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.

Secondary Outcome Measures

Name	Time	Method
Changes of blood insulin during OGTT.	8 weeks	Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.
Changes of glycated albumin, fructosamine, and lipid profile	8 weeks	Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention

Trial Locations

Locations (1)

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