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Completed

NCT Number: NCT01826409

Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes

This study was conducted to investigate the effects of daily supplementation of fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.

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Key information

Conditions

Impaired Glucose or Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clincial Trial Center for Functional Foods

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

About this study

This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance test were assessed before and after the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 20-75 years with fasting glucose 100~140 mg/dL at least two of the following

Exclusion criteria

  • Lipid metabolic disorder
  • Acute or chronic inflammatory disease
  • Taking medication of corticosteroid within 4 weeks of the study
  • Cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker)
  • Allergic or hypersensitive to any of the ingredients in the test products
  • Participation in other clinical trials within 2 months
  • Abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome)
  • Taking medication of lipid phosphates within 3 months of the study etc,

Treatment and study plan

Fermented Red Ginseng

Dietary Supplement

Fermented red ginseng 2.7g/day for 4 weeks

Placebo

Dietary Supplement

Placebo 2.7g/day for 4 weeks

Primary outcomes

  1. Glucose profiles during meal tolerance test

    Time frame: 4 weeks

    Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention

Secondary outcomes

  1. Change in lipid profiles

    Time frame: 4 weeks

    Change in lipid profiles were assessed before(baseline) and after the intervention

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Apr 8, 2013
Registry last updated
Aug 29, 2013

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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