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Effect of Aged Garlic Extract on Atherosclerosis (Garlic4)

This study has been completed.
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: March 9, 2017
Last verified: March 2017
February 14, 2012
March 9, 2017
May 2012
December 2014   (Final data collection date for primary outcome measure)
CT Angiography Plaque [ Time Frame: baseline to 1 year ]

we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as [followup-baseline]/baseline x100%.

Baseline was time zero, followup CT scan was 1 year.

improvement of vascular function [ Time Frame: 1 year ]
evaluating vascular function of the coronaries as based upon CT angiography
Complete list of historical versions of study NCT01534910 on ClinicalTrials.gov Archive Site
Coronary Calcium [ Time Frame: 1 year ]
Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: >400
  • Coronary Calcium [ Time Frame: 1 year ]
  • CT angiography plaque [ Time Frame: 1 year ]
  • Serum Biomarkers [ Time Frame: 1 year ]
    cholesterol, inflammatory markers, oxidative biomarkers.
  • Carotid IMT [ Time Frame: 1 year ]
    intima-media thickness
Not Provided
Not Provided
 
Effect of Aged Garlic Extract on Atherosclerosis
Effect of Aged Garlic Extract on Atherosclerosis
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.
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. The study will perform advanced CT angiography at baseline and follow up along with carotid intimal media thickness testing, to see if plaque is slowed down by Aged Garlic Extract
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Metabolic Syndrome
  • Drug: aged garlic extract
    2400 mg a day
    Other Name: Kyolic
  • Drug: placebo
    placebo
  • Placebo Comparator: Sugar pill
    placebo
    Intervention: Drug: placebo
  • Active Comparator: Aged Garlic Extract
    2400 mg of aged garlic extract
    Intervention: Drug: aged garlic extract
Matsumoto S, Nakanishi R, Li D, Alani A, Rezaeian P, Prabhu S, Abraham J, Fahmy MA, Dailing C, Flores F, Hamal S, Broersen A, Kitslaar PH, Budoff MJ. Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients with Metabolic Syndrome in a Prospective Randomized Double-Blind Study. J Nutr. 2016 Feb;146(2):427S-432S. doi: 10.3945/jn.114.202424. Epub 2016 Jan 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01534910
21567-01
No
Not Provided
No
Not Provided
Los Angeles Biomedical Research Institute
Los Angeles Biomedical Research Institute
Wakunaga Pharmaceutical Co., Ltd.
Principal Investigator: Matthew Budoff, MD Los Angeles Biomedical Research Institute
Los Angeles Biomedical Research Institute
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP