Trial Outcomes & Findings for Effect of Aged Garlic Extract on Atherosclerosis (NCT NCT01534910)

Results Overview

we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as \[followup-baseline\]/baseline x100%. Baseline was time zero, followup CT scan was 1 year.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

baseline to 1 year

Results posted on

2017-04-20

Participant Flow

all 65 participants were recruited

Participant milestones

Participant milestones
Measure	Sugar Pill placebo placebo: placebo	Aged Garlic Extract 2400 mg of aged garlic extract aged garlic extract: 2400 mg a day
Overall Study STARTED	33	32
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Aged Garlic Extract on Atherosclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=33 Participants placebo placebo: placebo patients were randomized to placebo	Aged Garlic Extract n=32 Participants 2400 mg of aged garlic extract aged garlic extract: 2400 mg a day patients randomized to aged garlic extract	Total n=65 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	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 7 • n=5 Participants	56 years STANDARD_DEVIATION 8 • n=7 Participants	57 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 1 year

we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as \[followup-baseline\]/baseline x100%. Baseline was time zero, followup CT scan was 1 year.

Outcome measures

Outcome measures
Measure	Sugar Pill n=28 Participants placebo placebo: placebo patients were randomized to placebo No adverse events	Aged Garlic Extract n=27 Participants 2400 mg of aged garlic extract aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events
CT Angiography Plaque	0.17 percent change of low attenuation plaque Standard Deviation 1.97	-1.53 percent change of low attenuation plaque Standard Deviation 2.32

SECONDARY outcome

Timeframe: 1 year

Population: patients undergoing two calcium scores

Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: \>400

Outcome measures

Outcome measures
Measure	Sugar Pill n=28 Participants placebo placebo: placebo patients were randomized to placebo No adverse events	Aged Garlic Extract n=27 Participants 2400 mg of aged garlic extract aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events
Coronary Calcium	95 agatston units Interval 74.0 to 116.0	49 agatston units Interval 20.0 to 78.0

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aged Garlic Extract

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 Matthew Budoff

Los Angeles Biomedical Research Institute

Phone: 310-222-4107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place