Trial Outcomes & Findings for A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia (NCT NCT01402102)

Results Overview

LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-10-12

Participant Flow

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

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

Participant milestones

Participant milestones
Measure	Aged Garlic Powder Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo Oral intake placebo(6.0g/day) for 12weeks
Overall Study STARTED	30	30
Overall Study COMPLETED	28	27
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Aged Garlic Powder Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo Oral intake placebo(6.0g/day) for 12weeks
Overall Study Protocol Violation	1	0
Overall Study Insufficiency of compliance	1	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aged Garlic Powder n=30 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=30 Participants Oral intake placebo(6.0g/day) for 12weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age Continuous	50.1 years STANDARD_DEVIATION 9.2 • n=5 Participants	50.8 years STANDARD_DEVIATION 8 • n=7 Participants	50.5 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Korea, Republic of	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Aged Garlic Powder n=28 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=27 Participants Oral intake placebo(6.0g/day) for 12weeks
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) Pre	150.6 mg/dl Standard Deviation 14.1	150.1 mg/dl Standard Deviation 15.7
Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol) Post	155.8 mg/dl Standard Deviation 21.9	156.3 mg/dl Standard Deviation 29.8

SECONDARY outcome

Timeframe: 12 weeks

Population: PP analysis

HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Aged Garlic Powder n=28 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=27 Participants Oral intake placebo(6.0g/day) for 12weeks
Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) Pre	46.86 mg/dl Standard Deviation 9.40	50.81 mg/dl Standard Deviation 9.19
Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol) Post	50.36 mg/dl Standard Deviation 8.85	50.48 mg/dl Standard Deviation 9.76

SECONDARY outcome

Timeframe: 12 weeks

Population: PP analysis

Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Aged Garlic Powder n=28 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=27 Participants Oral intake placebo(6.0g/day) for 12weeks
Changes in Triglycerides Pre	139.79 mg/dl Standard Deviation 54.55	124.11 mg/dl Standard Deviation 47.65
Changes in Triglycerides Post	120.21 mg/dl Standard Deviation 63.61	128.11 mg/dl Standard Deviation 65.50

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Aged Garlic Powder n=28 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=27 Participants Oral intake placebo(6.0g/day) for 12weeks
Changes in Total Cholesterol Pre	241.07 mg/dL Standard Deviation 23.97	228.93 mg/dL Standard Deviation 20.01
Changes in Total Cholesterol Post	233.50 mg/dL Standard Deviation 24.63	227.33 mg/dL Standard Deviation 32.51

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Aged Garlic Powder n=28 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=27 Participants Oral intake placebo(6.0g/day) for 12weeks
Changes in Apo-A1(Apolipoprotein A1) Pre	1.48 g/L Standard Deviation 0.21	1.43 g/L Standard Deviation 0.18
Changes in Apo-A1(Apolipoprotein A1) Post	1.41 g/L Standard Deviation 0.19	1.39 g/L Standard Deviation 0.17

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Aged Garlic Powder n=28 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=27 Participants Oral intake placebo(6.0g/day) for 12weeks
Changes in Apo-B(Apolipoprotein B) Pre	1.21 g/L Standard Deviation 0.13	1.03 g/L Standard Deviation 0.14
Changes in Apo-B(Apolipoprotein B) Post	1.07 g/L Standard Deviation 0.12	1.01 g/L Standard Deviation 0.19

SECONDARY outcome

Timeframe: 12 weeks

Population: per protocol analysis

FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).

Outcome measures

Outcome measures
Measure	Aged Garlic Powder n=28 Participants Oral intake Aged garlic powder(6.0g/day) for 12weeks.	Placebo n=27 Participants Oral intake placebo(6.0g/day) for 12weeks
Changes in FFA(Free Fatty Acid) Pre	570.25 µEq/L Standard Deviation 193.02	554.04 µEq/L Standard Deviation 179.64
Changes in FFA(Free Fatty Acid) Post	618.14 µEq/L Standard Deviation 184.78	523.93 µEq/L Standard Deviation 222.93

Adverse Events

Aged Garlic Powder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dal-Sik Kim

Clinical trial center for Functional Food in Chonbuk Nat'l University Hospital

Phone: 82-63-250-1793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place