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

NCT00860847 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2015-03-12

Study results available
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Summary

1. Statement of Problem

According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress. Cholesterol therapy has been well demonstrated to reduce coronary plaque progression. However is certainly not the only factor in evaluating for progression of coronary artery disease (CAD), and other factors must play a role. Garlic therapy has been shown to retard atherosclerosis independently.
2. Hypothesis and Specific Aims The hypothesis of this proposal is: In comparison to the placebo group, Aged Garlic Extract (AGE) therapy + Coenzyme Q10 (CoQ10) will be effective in slowing progression of coronary artery calcification (CAC) in firefighters with established atherosclerosis, independent of baseline blood pressure, statin use or other cardiovascular risk factors.

Specific Aims:

1. Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo.
2. Compare whether degree of change in atherosclerotic coronary artery plaque burden will change at a different rate under the influence of Aged Garlic Extract + CoQ10 compared to placebo treatment.
3. Compare whether Aged Garlic Extract + CoQ10 therapy induces changes in baseline values including biological and biochemical parameters, such as LDL cholesterol, homocysteine, C-reactive protein (CRP), and endothelial function.

Conditions

  • Coronary Atherosclerosis
  • Coronary Artery Calcification
  • Coronary Stenosis

Interventions

DIETARY_SUPPLEMENT

Aged garlic extract and Coenzyme Q10

AGE (1200 mg) and CoQ10 (120 mg)

Sponsors & Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    lead OTHER

Principal Investigators

  • Matthew J Budoff, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
84 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860847 on ClinicalTrials.gov