Metabolic Syndrome
Conditions
Keywords
Korean red ginseng, metabolic syndrome, blood pressure, arterial stiffness, inflammation, oxidative stress
Brief summary
Five factor consisting of Metabolic syndrome is closely linked by insulin resistance. Until now, several studies have been performed about effects of Korea red ginseng on hypertension, diabetes, and hyperlipidemia, but not metabolic syndrome. The investigators hypothesize that Korean red ginseng could improve each constituents of metabolic syndrome, arterial stiffness, and inflammatory markers. The aim of this study is to determine effects of Korean red ginseng on cardiovascular risks in subjects with metabolic syndrome.
Detailed description
The details of study objective are followed by these: * comparison of blood pressure before and after Korean red ginseng administration * comparison of metabolic indicator before and after Korean red ginseng administration * comparison of oxidative stress and inflammatory markers before and after Korean red ginseng administration * comparison of arterial stiffness before and after Korean red ginseng administration
Interventions
DIETARY_SUPPLEMENTstarch
5 capsules three times everyday for 12 weeks
DIETARY_SUPPLEMENTKorean red ginseng
5 capsules (300 mg/capsule) three times everyday for 12 weeks
Sponsors
The Korean Society of Ginseng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(three or more of following five factors) * waist circumference(male: more than 90cm, female: more than 80cm) * blood pressure(systolic: more than 130mmHg, diastolic: more than 85mmHg) * fasting plasma glucose: more than 100mg/dL * fasting triglycerides: more than 150mg/dL * High-density lipoprotein(HDL)-cholesterol(male: less than 40mg/dL, female: less than 50mg/dL)
Exclusion criteria
(any one of following factors) * uncontrolled blood pressure(systolic: more than 160mmHg, diastolic: more than 100mmHg) or subjects taking blood pressure lowering drug * Type 2 diabetes patients or fasting plasma glucose more than 126mg/dL * triglyceride more than 400mg/dL, total cholesterol more than 250mg/dL * subjects taking antilipidemic drug * past history of coronary heart disease or cerebrovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Pre- and Post-treatment Systolic Blood Pressure | baseline and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) | baseline and 12 weeks |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Starch Capsule 5 capsules three times everyday for 12 weeks | 31 |
| Korea Red Ginseng 5 capsules (300mg/capsule) three times everyday for 12 weeks | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Starch Capsule | Korea Red Ginseng |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 29 Participants | 28 Participants |
| Age Continuous | 44.7 years STANDARD_DEVIATION 10.8 | 46.2 years STANDARD_DEVIATION 11 | 43.1 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Korea, Republic of | 60 participants | 31 participants | 29 participants |
| Sex: Female, Male Female | 21 Participants | 12 Participants | 9 Participants |
| Sex: Female, Male Male | 39 Participants | 19 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Change in the Pre- and Post-treatment Systolic Blood Pressure
Time frame: baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Starch Capsule | Change in the Pre- and Post-treatment Systolic Blood Pressure | Week 0 | 129.5 mm Hg | Standard Deviation 10.7 |
| Starch Capsule | Change in the Pre- and Post-treatment Systolic Blood Pressure | Week 12 | 122.6 mm Hg | Standard Deviation 13.2 |
| Korea Red Ginseng | Change in the Pre- and Post-treatment Systolic Blood Pressure | Week 0 | 134.5 mm Hg | Standard Deviation 12.5 |
| Korea Red Ginseng | Change in the Pre- and Post-treatment Systolic Blood Pressure | Week 12 | 127.5 mm Hg | Standard Deviation 13.6 |
Secondary
Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)
Time frame: baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Starch Capsule | Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) | 0 week | 83.3 uIU/mL | Standard Deviation 35.9 |
| Starch Capsule | Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) | 12 week | 83.4 uIU/mL | Standard Deviation 36.7 |
| Korea Red Ginseng | Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) | 0 week | 78.8 uIU/mL | Standard Deviation 37.2 |
| Korea Red Ginseng | Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL) | 12 week | 76.3 uIU/mL | Standard Deviation 29 |