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Completed

NCT Number: NCT01854164

Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose

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).

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGE (hydrolyzed ginseng extract)

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Changes of blood glucose during OGTT(oral glucose tolerance test)

    Time frame: 8 weeks

    Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.

Secondary outcomes

  1. Changes of blood insulin during OGTT.

    Time frame: 8 weeks

    Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.

  2. Changes of glycated albumin, fructosamine, and lipid profile

    Time frame: 8 weeks

    Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 15, 2013
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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