Effect of Aged Garlic Extract on Atherosclerosis

NCT ID: NCT01534910

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

Brief 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.

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

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar pill

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Aged Garlic Extract

2400 mg of aged garlic extract

Group Type: ACTIVE_COMPARATOR

aged garlic extract

Intervention Type: DRUG

2400 mg a day

Interventions

aged garlic extract

2400 mg a day

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Kyolic

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wakunaga Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Budoff, MD

Role: PRINCIPAL_INVESTIGATOR

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Locations

Los Angeles Biomedical Research Institute

Torrance, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26764322 (View on PubMed)

Other Identifiers

21567-01

Identifier Type: -

Identifier Source: org_study_id