search
Back to results

Effect of Aged Garlic Extract on Atherosclerosis (Garlic4)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
aged garlic extract
placebo
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring garlic, ct angiography, atherosclerosis, carotid IMT

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Los Angeles Biomedical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar pill

Aged Garlic Extract

Arm Description

placebo

2400 mg of aged garlic extract

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2012
Last Updated
March 9, 2017
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Wakunaga Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01534910
Brief Title
Effect of Aged Garlic Extract on Atherosclerosis
Acronym
Garlic4
Official Title
Effect of Aged Garlic Extract on Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Wakunaga Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
garlic, ct angiography, atherosclerosis, carotid IMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Aged Garlic Extract
Arm Type
Active Comparator
Arm Description
2400 mg of aged garlic extract
Intervention Type
Drug
Intervention Name(s)
aged garlic extract
Other Intervention Name(s)
Kyolic
Intervention Description
2400 mg a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
CT Angiography Plaque
Description
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.
Time Frame
baseline to 1 year
Secondary Outcome Measure Information:
Title
Coronary Calcium
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Budoff, MD
Organizational Affiliation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Biomedical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26764322
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Aged Garlic Extract on Atherosclerosis

We'll reach out to this number within 24 hrs