Effect of Korean Red Ginseng on Insulin Sensitivity in Non Diabetic Overweight Korean Adults (KRGIS)
Primary Purpose
Insulin Resistance, Obesity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Korea red ginseng
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance focused on measuring overweight,, ginseng
Eligibility 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
Sites / Locations
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Korea Red Ginseng
placebo contating constarch
Arm Description
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.
Outcomes
Primary Outcome Measures
insulin sensitivity (insulin, HOMA-IR, QUICKI)
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)]
Secondary Outcome Measures
Full Information
NCT ID
NCT01616134
First Posted
June 5, 2012
Last Updated
March 1, 2017
Sponsor
The Korean Society of Ginseng
1. Study Identification
Unique Protocol Identification Number
NCT01616134
Brief Title
Effect of Korean Red Ginseng on Insulin Sensitivity in Non Diabetic Overweight Korean Adults
Acronym
KRGIS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Korean Society of Ginseng
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity
Keywords
overweight,, ginseng
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Korea Red Ginseng
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo contating constarch
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Korea red ginseng
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The subjects in the Control group were given the same quantity of placebos also three times a day for 12 weeks.
Primary Outcome Measure Information:
Title
insulin sensitivity (insulin, HOMA-IR, QUICKI)
Description
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)]
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Korean Red Ginseng on Insulin Sensitivity in Non Diabetic Overweight Korean Adults
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