Effect of Korean Red Ginseng on Insulin Sensitivity in Non Diabetic Overweight Korean Adults (KRGIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sang-Yeoup Lee, The Korean Society of Ginseng
ClinicalTrials.gov Identifier:
NCT01616134
First received: June 5, 2012
Last updated: June 7, 2012
Last verified: June 2012
  Purpose

Korean red ginseng (KRG) is popular worldwide since it is believed to contain ingredients with a variety of health enhancement effects. Several in vitro studies and animal studies showed that ginseng has anti-obesity, anti-diabetic and anti-metabolic disease effects. Several studies involving type 2 diabetes mellitus (T2DM) patients reported that administration of KRG for 12 weeks resulted in positive effects on the maintenance of sugar control effect and improvement of insulin resistance Although there is evidence to suggest that KRG could efficacious reduction in postprandial glycemia, the benefits of long-term KRG in healthy individuals on insulin sensitivity has not yet been established. Therefore, we investigated whether KRG affected insulin sensitivity in healthy overweight or obese Korean subjects without overt diabetes.


Condition Intervention
Insulin Resistance,
Obesity
Other: Korea red ginseng
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by The Korean Society of Ginseng:

Primary Outcome Measures:
  • insulin sensitivity (insulin, HOMA-IR, QUICKI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Blood samples after a 12-h fast were taken at baseline and 12 weeks after randomization. Blood samples were taken after at least 8 hours of fasting for glucose, insulin, liver enzyme, creatinine and lipid test. The homeostasis model assessment index-insulin resistance (HOMA-IR) was calculated using a fomula: [fasting plasma insulin (µU/mL) × fasting plasma glucose (mg/dL)] / (22.5×18.182) and quantitative insulin-sensitivity check index (QUICKI) was calculated using a formula: 1 / [log fasting insulin (µU/mL) + log fasting blood sugar (mg/dL)]


Enrollment: 80
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Korea Red Ginseng
Intervention group were administered with 4 capsules (2 g) each of powdered red ginseng (6-year old , rootlets) 40 minutes before breakfast, lunch and dinner, totaling 12 capsules (6 g) per day, for 12 weeks.
Other: Korea red ginseng
Intervention group were administered with 4 capsules (2 g) each of powdered red ginseng (6-year old , rootlets) 40 minutes before breakfast, lunch and dinner, totaling 12 capsules (6 g) per day, for 12 weeks
Placebo Comparator: placebo contating constarch Other: Placebo
The subjects in the Control group were given the same quantity of placebos also three times a day for 12 weeks.

Detailed Description:

80 adults between the ages of 20 and 60 years and with a BMI ≥ 23 kg/m2 was initially enrolled. The subjects had not taken any supplements or medications, including anti-diabetic drugs, anti-hypertensive drugs, steroids, or hormonal products, during the previous 4 weeks.

This study had a randomized, placebo-controlled, double-blind controlled design. Each subject was randomized to either the Intervention group or the Control group. The subjects in the Intervention group were administered with 4 capsules (2 g) each of powdered red ginseng (6-year old , rootlets) 40 minutes before breakfast, lunch and dinner, totaling 12 capsules (6 g) per day, for 12 weeks. The subjects in the Control group were given the same quantity of placebos also three times a day for 12 weeks.

Blood samples after a 12-h fast were taken at baseline and 12 weeks after randomization. Blood samples were taken after at least 8 hours of fasting for general blood test, biochemical test and lipid test. Each subject's diet was monitored by a semi-quantitative FFQ at baseline and after 12 weeks. Participants were asked to report the frequency of consumption of 53 food items contained in the semi-quantitative FFQ over the 2 weeks prior to administration by an experienced dietitian. Excessive drinking was defined according to the guidelines of the National Institute Alcohol Abuse and Alcoholism when more than 14 glasses (alcohol 196 g) are consumed for male and 7 glasses (alcohol 98 g) for female. Physical activity was assessed using the International Physical Activity Questionnaire at baseline and after 12 weeks. We expressed physical activity levels as MET-minute. METs are multiples of the resting metabolic rates. A MET-minute is computed by multiplying the MET score of an activity by the minutes performed. MET-minute scores are equivalent to kilocalories for a 60 kilogram person.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages of 20 and 60 years
  • BMI ≥ 23 kg/m2

Exclusion Criteria:

  • any supplements or medications, including anti-diabetic drugs, anti-hypertensive drugs, steroids, or hormonal products, during the previous 4 weeks
  • participant's systolic BP was above 140 mmHg or diastolic BP above 90 mmHg
  • above 100 m/dL before enrollment in the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01616134

Locations
Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, Korea, Republic of, 626-770
Sponsors and Collaborators
The Korean Society of Ginseng
  More Information

No publications provided

Responsible Party: Sang-Yeoup Lee, Pusan national iniversity Yangsan Hospital, The Korean Society of Ginseng
ClinicalTrials.gov Identifier: NCT01616134     History of Changes
Other Study ID Numbers: KRG-0912
Study First Received: June 5, 2012
Last Updated: June 7, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Korean Society of Ginseng:
overweight,
ginseng

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014