Effect of Aged Garlic Extract on Atherosclerosis

NCT01534910 | Completed Phase 4 Results

• 1 other identifier: 21567-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

garlic; ct angiography; atherosclerosis; carotid IMT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Coronary Calcium

  1 year

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

placebo

Drug: placebo

Aged Garlic Extract

ACTIVE COMPARATOR

2400 mg of aged garlic extract

Drug: aged garlic extract

Interventions

aged garlic extract DRUG

2400 mg a day

Also known as: Kyolic

Aged Garlic Extract

placebo DRUG

placebo

Sugar pill

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

Related Publications (1)

• 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.

  PMID: 26764322 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Atherosclerosis

Interventions

kyolic

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Matthew Budoff
• Organization: Los Angeles Biomedical Research Institute

mbudoff@labiomed.org

310-222-4107

Study Officials

• Matthew Budoff, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 17, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 20, 2017
• Results First Posted: April 3, 2015

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)