Hyperlipidemia
Conditions
Keywords
Aged garlic, Hyperlipidemic, LDL, HDL, Triglyceride
Brief summary
We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects who were given aged garlic powder over a period of 12 weeks. We measured serum lipids, including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood pressure.
Detailed description
An increased serum cholesterol level is an important risk factor for the development of cardiovascular and cerebrovascular disease. Reduction of these and other risk factors through dietary modification, behavioral changes, and medicinal intervention has already substantially decreased the incidence and mortality from cardiovascular and cerebrovascular disease. Supplementation of the diet with certain biofactors may further reduce such risk factors. Aged garlic belongs to a group of dietary supplements that may lessen the incidence of cardiovascular and cerebrovascular disease by reducing lipids levels and decreasing platelet responsiveness to activating agents.
Interventions
DIETARY_SUPPLEMENTAged garlic powder
Aged garlic powder(6.0g/day)
DIETARY_SUPPLEMENTPlacebo powder
Placebo powder(6.0g/day)
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Mild hypercholesterolemic subjects aged from 20 to 80 years * had no received lipid-lowering drugs for at least 3 months prior to the recruitment
Exclusion criteria
* self-reported pregnancy,lactation * prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) | 12 weeks | LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Triglycerides | 12 weeks | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in Total Cholesterol | 12 weeks | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) | 12 weeks | HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in Apo-B(Apolipoprotein B) | 12 weeks | Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in FFA(Free Fatty Acid) | 12 weeks | FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week). |
| Changes in Apo-A1(Apolipoprotein A1) | 12 weeks | Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week). |
Countries
South Korea
Participant flow
Recruitment details
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
Pre-assignment details
The criteria were an age from 20 to 80 years, a BMI(Body Mass Index)\>23 kg/m\^2, an LDL-C(Low Density Lipoprotein-cholesterol) concentration between 130 and 220 mg/dL. Subjects were excluded if they had heart disease, liver or kidney disease, irregular lifestyle habits, or if they took medication and functional foods known to affect lipid metabolism
Participants by arm
| Arm | Count |
|---|---|
| Aged Garlic Powder Oral intake Aged garlic powder(6.0g/day) for 12weeks. | 30 |
| Placebo Oral intake placebo(6.0g/day) for 12weeks | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Insufficiency of compliance | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | Aged Garlic Powder | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 22 Participants | 46 Participants |
| Age Continuous | 50.8 years STANDARD_DEVIATION 8 | 50.1 years STANDARD_DEVIATION 9.2 | 50.5 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment Korea, Republic of | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 22 Participants | 18 Participants | 40 Participants |
| Sex: Female, Male Male | 8 Participants | 12 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 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)
LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aged Garlic Powder | Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) | Pre | 150.6 mg/dl | Standard Deviation 14.1 |
| Aged Garlic Powder | Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) | Post | 155.8 mg/dl | Standard Deviation 21.9 |
| Placebo | Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) | Post | 156.3 mg/dl | Standard Deviation 29.8 |
| Placebo | Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) | Pre | 150.1 mg/dl | Standard Deviation 15.7 |
Secondary
Changes in Apo-A1(Apolipoprotein A1)
Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aged Garlic Powder | Changes in Apo-A1(Apolipoprotein A1) | Post | 1.41 g/L | Standard Deviation 0.19 |
| Aged Garlic Powder | Changes in Apo-A1(Apolipoprotein A1) | Pre | 1.48 g/L | Standard Deviation 0.21 |
| Placebo | Changes in Apo-A1(Apolipoprotein A1) | Post | 1.39 g/L | Standard Deviation 0.17 |
| Placebo | Changes in Apo-A1(Apolipoprotein A1) | Pre | 1.43 g/L | Standard Deviation 0.18 |
Secondary
Changes in Apo-B(Apolipoprotein B)
Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aged Garlic Powder | Changes in Apo-B(Apolipoprotein B) | Pre | 1.21 g/L | Standard Deviation 0.13 |
| Aged Garlic Powder | Changes in Apo-B(Apolipoprotein B) | Post | 1.07 g/L | Standard Deviation 0.12 |
| Placebo | Changes in Apo-B(Apolipoprotein B) | Pre | 1.03 g/L | Standard Deviation 0.14 |
| Placebo | Changes in Apo-B(Apolipoprotein B) | Post | 1.01 g/L | Standard Deviation 0.19 |
Secondary
Changes in FFA(Free Fatty Acid)
FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aged Garlic Powder | Changes in FFA(Free Fatty Acid) | Pre | 570.25 µEq/L | Standard Deviation 193.02 |
| Aged Garlic Powder | Changes in FFA(Free Fatty Acid) | Post | 618.14 µEq/L | Standard Deviation 184.78 |
| Placebo | Changes in FFA(Free Fatty Acid) | Pre | 554.04 µEq/L | Standard Deviation 179.64 |
| Placebo | Changes in FFA(Free Fatty Acid) | Post | 523.93 µEq/L | Standard Deviation 222.93 |
Secondary
Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)
HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: PP analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aged Garlic Powder | Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) | Pre | 46.86 mg/dl | Standard Deviation 9.4 |
| Aged Garlic Powder | Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) | Post | 50.36 mg/dl | Standard Deviation 8.85 |
| Placebo | Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) | Pre | 50.81 mg/dl | Standard Deviation 9.19 |
| Placebo | Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) | Post | 50.48 mg/dl | Standard Deviation 9.76 |
Secondary
Changes in Total Cholesterol
Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aged Garlic Powder | Changes in Total Cholesterol | Pre | 241.07 mg/dL | Standard Deviation 23.97 |
| Aged Garlic Powder | Changes in Total Cholesterol | Post | 233.50 mg/dL | Standard Deviation 24.63 |
| Placebo | Changes in Total Cholesterol | Pre | 228.93 mg/dL | Standard Deviation 20.01 |
| Placebo | Changes in Total Cholesterol | Post | 227.33 mg/dL | Standard Deviation 32.51 |
Secondary
Changes in Triglycerides
Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).
Time frame: 12 weeks
Population: PP analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aged Garlic Powder | Changes in Triglycerides | Pre | 139.79 mg/dl | Standard Deviation 54.55 |
| Aged Garlic Powder | Changes in Triglycerides | Post | 120.21 mg/dl | Standard Deviation 63.61 |
| Placebo | Changes in Triglycerides | Pre | 124.11 mg/dl | Standard Deviation 47.65 |
| Placebo | Changes in Triglycerides | Post | 128.11 mg/dl | Standard Deviation 65.5 |