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

February 28, 2015 updated by: Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria

  • Calcium scan with Agatston score >20
  • Age 35-84 years
  • Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
  • Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization
  • Subjects who agree to refrain from supplemental garlic or significant dietary garlic

Exclusion Criteria

  • A contraindication to Aged Garlic Extract therapy including: known hypersensitivity to drug.
  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
  • Weight in excess of 325 pounds
  • Bleeding disorder
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
  • Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting blood pressure > 170 mm Hg or a resting diastolic blood pressure of >110 mm Hg)
  • NYHA Class III or IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Serum creatinine > 1.4 mg/dl
  • Triglycerides > 400 at visit 1
  • Diabetic subjects with HbA1c > 12%
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude accurate measure of coronary calcification
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • Current intake of garlic supplement or other prohibited drug (Appendix B)
  • Current tobacco use
  • Current use of anticoagulants (except for antiplatelet agents)
  • Chronic renal failure
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI

Outcome Measures Primary - Rate of change in total coronary calcium scores by CT 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.

Secondary Change in blood values and endothelial function over 6 and 12 months:

  1. Plasma lipids: total plasma cholesterol and triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol determined by the precipitation method;
  2. Endothelial markers and inflammation: C-reactive protein and Homocysteine, as well as GSH

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90005
        • Los Angeles Biomedical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Calcium scan with Agatston score >20
  • Age 35-84 years
  • Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
  • Subjects should be stable on their concomitant medications for at least 12 weeks prior to randomization
  • Subjects who agree to refrain from supplemental garlic or significant dietary garlic

Exclusion Criteria:

  • A contraindication to Aged Garlic Extract therapy including: known hypersensitivity to drug.
  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
  • Weight in excess of 325 pounds
  • Bleeding disorder
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
  • Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting blood pressure > 170 mm Hg or a resting diastolic blood pressure of >110 mm Hg)
  • NYHA Class III or IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Serum creatinine > 1.4 mg/dl
  • Triglycerides > 400 at visit 1
  • Diabetic subjects with HbA1c > 12%
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude accurate measure of coronary calcification
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • Current intake of garlic supplement or other prohibited drug (Appendix B)
  • Current tobacco use
  • Current use of anticoagulants (except for antiplatelet agents)
  • Chronic renal failure
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aged Garlic Extract and Coenzyme Q10

AGE (1200 mg) and CoQ10 (120 mg)

This is a combination of aged garlic extract and co-enzyme Q10
Dietary supplement: Aged garlic extract and Coenzyme Q10
AGE (1200 mg) and CoQ10 (120 mg)
Other Names:
  • Kyolic formula 110
No Intervention: Placebo
placebo pills will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Change in Total Coronary Calcium Scores by Computed Tomography
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Investigators

  • Principal Investigator: Matthew J Budoff, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

February 28, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wakunaga of America Co., Ltd.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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