Trial Outcomes & Findings for Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH) (NCT NCT00860847)

Results Overview

progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm\^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

65 participants

Primary outcome timeframe

1 year

Results posted on

2015-03-12

Participant Flow

65 patients were recruited

completed

Participant milestones

Participant milestones
Measure	Aged Garlic Extract and Coenzyme Q10 Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)	Placebo Patients randomized to placebo
Overall Study STARTED	32	33
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aged Garlic Extract and Coenzyme Q10 n=32 Participants Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)	Placebo n=33 Participants Patients randomized to placebo	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	32 Participants n=5 Participants	33 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	55 years STANDARD_DEVIATION 6 • n=5 Participants	55 years STANDARD_DEVIATION 6 • n=7 Participants	55 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: all participants were analyzed

progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm\^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.

Outcome measures

Outcome measures
Measure	Aged Garlic Extract and Coenzyme Q10 n=32 Participants Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)	Placebo n=33 Participants Patients randomized to placebo
Rate of Change in Total Coronary Calcium Scores by Computed Tomography	32 Agatston score change Standard Deviation 6	58 Agatston score change Standard Deviation 8

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

Adverse Events

Aged Garlic Extract and Coenzyme Q10

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 Matthew Budoff

Los Angeles Biomedical Research Inst.

Phone: 310-222-4107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place