NCT00860847

Brief Summary

  1. 1.Statement of Problem
  2. 2.Hypothesis and Specific Aims The hypothesis of this proposal is: In comparison to the placebo group, Aged Garlic Extract (AGE) therapy + Coenzyme Q10 (CoQ10) will be effective in slowing progression of coronary artery calcification (CAC) in firefighters with established atherosclerosis, independent of baseline blood pressure, statin use or other cardiovascular risk factors.
  3. 3.Compare the effects of cholesterol lowering effects in a firefighter population of patients under the influence of Aged Garlic Extract + CoQ10 or placebo.
  4. 4.Compare whether degree of change in atherosclerotic coronary artery plaque burden will change at a different rate under the influence of Aged Garlic Extract + CoQ10 compared to placebo treatment.
  5. 5.Compare whether Aged Garlic Extract + CoQ10 therapy induces changes in baseline values including biological and biochemical parameters, such as LDL cholesterol, homocysteine, C-reactive protein (CRP), and endothelial function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 12, 2015

Completed
Last Updated

March 12, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

March 11, 2009

Results QC Date

January 27, 2013

Last Update Submit

February 28, 2015

Conditions

Coronary AtherosclerosisCoronary Artery CalcificationCoronary Stenosis

Keywords

Progression of AtherosclerosisAged garlic extractBiomarkers of inflammationCoronary Plaque Volume and coronary StenosisVascular function

Outcome Measures

Primary Outcomes (1)

  • Rate of Change in Total Coronary Calcium Scores by Computed Tomography

    progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm\^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.

    1 year

Secondary Outcomes (1)

  • 1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH

    1 year

Study Arms (2)

Aged Garlic Extract and Coenzyme Q10

ACTIVE COMPARATOR

AGE (1200 mg) and CoQ10 (120 mg) This is a combination of aged garlic extract and co-enzyme Q10

Dietary Supplement: Aged garlic extract and Coenzyme Q10

Placebo

NO INTERVENTION

placebo pills will be given

Interventions

Aged garlic extract and Coenzyme Q10DIETARY_SUPPLEMENT

AGE (1200 mg) and CoQ10 (120 mg)

Also known as: Kyolic formula 110
Aged Garlic Extract and Coenzyme Q10

Eligibility Criteria

Age35 Years - 84 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Calcium scan with Agatston score \>20
  • Age 35-84 years
  • 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 12 weeks prior to randomization
  • Subjects who agree to refrain from supplemental garlic or significant dietary garlic

You may not qualify if:

  • A contraindication to Aged Garlic Extract therapy 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 325 pounds
  • Bleeding disorder
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
  • Resting hypotension (a resting systolic blood pressure of \<90 mm Hg) or hypertension (a resting blood pressure \> 170 mm Hg or a resting diastolic blood pressure of \>110 mm Hg)
  • NYHA Class III or 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
  • Triglycerides \> 400 at visit 1
  • Diabetic subjects with HbA1c \> 12%
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Presence of metal clips (i.e. bypass patients) or intracoronary stenting that preclude accurate measure of coronary calcification
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90005, United States

Location

Related Publications (9)

  • Libby P, Schoenbeck U, Mach F, Selwyn AP, Ganz P. Current concepts in cardiovascular pathology: the role of LDL cholesterol in plaque rupture and stabilization. Am J Med. 1998 Feb 23;104(2A):14S-18S. doi: 10.1016/s0002-9343(98)00041-2.

    PMID: 9550502BACKGROUND

  • Lau BH, Li L, Yoon P. Thymic peptide protects vascular endothelial cells from hydrogen peroxide-induced oxidant injury. Life Sci. 1993;52(22):1787-96. doi: 10.1016/0024-3205(93)90468-i.

    PMID: 8492641BACKGROUND

  • Weissberg PL, Bennett MR. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jun 17;340(24):1928-9. No abstract available.

    PMID: 10375320BACKGROUND

  • Raggi P, Callister TQ, Shaw LJ. Progression of coronary artery calcium and risk of first myocardial infarction in patients receiving cholesterol-lowering therapy. Arterioscler Thromb Vasc Biol. 2004 Jul;24(7):1272-7. doi: 10.1161/01.ATV.0000127024.40516.ef. Epub 2004 Apr 1.

    PMID: 15059806BACKGROUND

  • Budoff MJ, Takasu J, Flores FR, Niihara Y, Lu B, Lau BH, Rosen RT, Amagase H. Inhibiting progression of coronary calcification using Aged Garlic Extract in patients receiving statin therapy: a preliminary study. Prev Med. 2004 Nov;39(5):985-91. doi: 10.1016/j.ypmed.2004.04.012.

    PMID: 15475033BACKGROUND

  • Steiner M, Lin RS. Changes in platelet function and susceptibility of lipoproteins to oxidation associated with administration of aged garlic extract. J Cardiovasc Pharmacol. 1998 Jun;31(6):904-8. doi: 10.1097/00005344-199806000-00014.

    PMID: 9641475BACKGROUND

  • BEUTLER E, DURON O, KELLY BM. Improved method for the determination of blood glutathione. J Lab Clin Med. 1963 May;61:882-8. No abstract available.

    PMID: 13967893BACKGROUND

  • Mao S, Bakhsheshi H, Lu B, Liu SC, Oudiz RJ, Budoff MJ. Effect of electrocardiogram triggering on reproducibility of coronary artery calcium scoring. Radiology. 2001 Sep;220(3):707-11. doi: 10.1148/radiol.2203001129.

    PMID: 11526270BACKGROUND

  • Ahmadi N, Hajsadeghi F, Gul K, Vane J, Usman N, Flores F, Nasir K, Hecht H, Naghavi M, Budoff M. Relations between digital thermal monitoring of vascular function, the Framingham risk score, and coronary artery calcium score. J Cardiovasc Comput Tomogr. 2008 Nov;2(6):382-8. doi: 10.1016/j.jcct.2008.09.001. Epub 2008 Sep 26.

    PMID: 19083982BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Stenosis

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Dr Matthew Budoff
Organization
Los Angeles Biomedical Research Inst.
mbudoff@labiomed.org
310-222-4107

Study Officials

  • Matthew J Budoff, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

March 12, 2015

Results First Posted

March 12, 2015

Record last verified: 2015-02

Locations

US(1)