Effect of Aged Garlic Extract on Atherosclerosis (Garlic4)

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Drug: placebo; Drug: aged garlic extract

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other Names: Kyolic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT Angiography Plaque	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.	baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary Calcium	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	1 year

Collaborators and Investigators

• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Collaborators: Wakunaga Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 14, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: atherosclerosis; garlic; ct angiography; carotid IMT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Atherosclerosis
• Other Study ID Numbers: 21567-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No