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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Los Angeles Biomedical Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00860847
First received: March 11, 2009
Last updated: May 6, 2010
Last verified: May 2010
  Purpose
  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.

Condition Intervention Phase
Coronary Atherosclerosis
Coronary Artery Calcification
Coronary Stenosis
Vascular Function
Dietary Supplement: Aged garlic extract and Coenzyme Q10
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Rate of change in total coronary calcium scores by computed tomography [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: May 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aged Garlic Extract and Coenzyme Q10
AGE (1200 mg) and CoQ10 (120 mg)
Dietary Supplement: Aged garlic extract and Coenzyme Q10
AGE (1200 mg) and CoQ10 (120 mg)
Other Name: Kyolic formula 110
No Intervention: Placebo

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

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
  Eligibility

Ages Eligible for Study:   35 Years to 84 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860847

Locations
United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90005
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Matthew J Budoff, MD University of California, Los Angeles
  More Information

Additional Information:
Publications:

Responsible Party: Matthew J Budoff, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00860847     History of Changes
Other Study ID Numbers: Wakunaga of America Co., Ltd.
Study First Received: March 11, 2009
Last Updated: May 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Los Angeles Biomedical Research Institute:
Progression of Atherosclerosis
Aged garlic extract
Biomarkers of inflammation
Coronary Plaque Volume and coronary Stenosis
Vascular function

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Calcinosis
Coronary Artery Disease
Coronary Stenosis
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Calcium Metabolism Disorders
Cardiovascular Diseases
Coronary Disease
Metabolic Diseases
Vascular Diseases
Coenzyme Q10
Ubiquinone
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014