Effect of Aged Garlic Extract on Atherosclerosis
Condition: Metabolic Syndrome
MeSH terms: Atherosclerosis; Metabolic Syndrome
Intervention: aged garlic extract; placebo
Intervention description: 2400 mg a day; placebo
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: garlic; ct angiography; atherosclerosis; carotid IMT

Summary:

      The investigators will be assessing the effect of Aged Garlic Extract on the coronary
      arteries. The investigators will enroll patients in a double blind study, where half the
      patients will receive placebo, and have the patients undergo a series of tests of plaque (CT
      scan of the heart, carotid ultrasound) and follow the patients on the drug or placebo and
      then repeat the tests and blood work at the end of one year. The investigators will assess if
      being on aged garlic extract adds any benefit to plaque in the coronary or neck arteries. The
      investigators will also assess the effect of aged garlic extract on markers of inflammation.
      Patients will receive free drug, free testing and be compensated, and learn more about their
      heart and neck arteries. if successful, more patients can use this drug to benefit their
      health. The harms include the radiation from the CT scan and the medication, which has mild
      side effects.
    

Eligibility criteria:

        Inclusion Criteria

          -  Age 40-65 years

          -  Framingham risk score 6-20%, and at least 2 components of the metabolic syndrome as
             defined by ATP III Clinical Identification of the Metabolic Syndrome (including
             impaired fasting glucose > 110 mg/dl, treated hypertension or SBP > 130 or DBP > 85 mm
             Hg, plasma triglycerides > 150 mg/dl, HDL cholesterol < 35 mg/dl for men or < 40 mg/dl
             for women, abdominal obesity as defined as waist > 40 in for men, > 35 in for women)

          -  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 26 weeks prior
             to randomization

          -  Calcium Score > 20 at baseline

          -  Subjects who agree to refrain from other anti-glycemic agent Exclusion Criteria

          -  A contraindication to AGE 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 300 pounds

          -  Bleeding disorder

          -  History of known coronary artery disease, myocardial infarction, stroke or
             life-threatening arrhythmia within the prior six months

          -  NYHA Class II- 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

          -  Diabetes Mellitus

          -  Triglycerides > 400 at visit 1

          -  Drug or alcohol abuse, or current intake of more than 14 standard drinks per week

          -  Concurrent enrollment in another placebo-controlled trial

          -  Partial ileal bypass or known gastrointestinal disease limiting drug absorption

          -  Current diabetes or intake of anti-diabetic or other prohibited drug

          -  Current tobacco use

          -  Current use of anticoagulants (except for anti-platelet agents)

          -  Renal failure

          -  History of hypertensive encephalopathy or cerebrovascular accident

          -  Hematological or biochemical values at screening outside the reference ranges
             considered as clinically significant in the opinion of the investigator or PI