Effect of Aged Garlic Extract on Atherosclerosis (Garlic4)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT01534910
First received: February 14, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Drug: aged garlic extract
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Aged Garlic Extract on Atherosclerosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • improvement of vascular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    evaluating vascular function of the coronaries as based upon CT angiography


Secondary Outcome Measures:
  • Coronary calcium [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • CT angiography plaque [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum Biomarkers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    cholesterol, inflammatory markers, oxidative biomarkers.

  • Carotid IMT [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    intima-media thickness


Estimated Enrollment: 65
Study Start Date: May 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
placebo
Drug: placebo
placebo
Active Comparator: Aged Garlic Extract
2400 mg of aged garlic extract
Drug: aged garlic extract
2400 mg a day

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT01534910

Locations
United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Wakunaga Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Matthew Budoff, MD Los Angeles Biomedical Research Institute
  More Information

No publications provided

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01534910     History of Changes
Other Study ID Numbers: Garlic4
Study First Received: February 14, 2012
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Los Angeles Biomedical Research Institute:
garlic
ct angiography
atherosclerosis
carotid IMT

Additional relevant MeSH terms:
Atherosclerosis
Metabolic Syndrome X
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014