Effect of Aged Garlic Extract on Atherosclerosis

Metabolic Syndrome Clinical Trial

— Garlic4  

Official title:

Effect of Aged Garlic Extract on Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534910
• Other study ID #: Garlic4
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2012
• Last updated: March 19, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• aged garlic extract
2400 mg a day
• placebo
placebo

Locations

Country	Name	City	State
United States	Los Angeles Biomedical Research Institute	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute	Wakunaga Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT Angiography Plaque	we measured low attenuation plaque at baseline (in volume) and then again at 1 year. In a double-blinded analysis, there was reduction in low attenuation plaque volume (percent of change from baseline, defined as [followup-baseline]/baseline x100%.; Baseline was time zero, followup CT scan was 1 year. For this measure (Low attenuation plaque), we had 28 interpretable baseline and follow up images to use in placebo(sugar pill), for Aged garlic extract, we had 27 interpretable paired data sets (both baseline and follow up had to be interpretable to use the measure).	1 year	No
Secondary	Coronary Calcium		1 year	No
Secondary	Serum Biomarkers	cholesterol, inflammatory markers, oxidative biomarkers.	1 year	No
Secondary	Carotid IMT	intima-media thickness	1 year	No