Metabolic SyndromePhase 4Garlic4NCT01534910
Effect of Aged Garlic Extract on Atherosclerosis
A Phase 4 study testing aged garlic extract in people with Metabolic Syndrome, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- aged garlic extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 25Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
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.
Read the 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
- Being tested
- aged garlic extract, placebo
- Keywords
- garlic, ct angiography, atherosclerosis, carotid IMT
- Medical subject headings
- Metabolic Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aged garlic extractDrug
Also called Kyolic
2400 mg a day
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | placebo Receives: Drug: placebo |
| Aged Garlic Extract | Active comparator | 2400 mg of aged garlic extract Receives: Drug: aged garlic extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Matthew Budoff, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534910
- Sponsor's protocol ID
- 21567-01
- Acronym
- Garlic4
- Status last verified
- Mar 2017
- First submitted
- 14 Feb 2012
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26764322
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aged Garlic Extract on Atherosclerosis
- ClinicalTrials.gov ID
- NCT01534910
- Acronym / sponsor ID
- Garlic4 / 21567-01
- Conditions
- Metabolic Syndrome
- Keywords
- garlic, ct angiography, atherosclerosis, carotid IMT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 3 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: placeboplacebo |
| Aged Garlic Extract | Active comparator | Drug: aged garlic extract2400 mg of aged garlic extract |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aged garlic extractAlso: Kyolic2400 mg a day | Drug | Aged Garlic Extract |
| placeboplacebo | Drug | Sugar pill |
Primary outcome
CT Angiography Plaque
Time frame: baseline to 1 year
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.
1 secondary outcome
Coronary Calcium
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26764322Matsumoto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Budoff, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aged garlic extract in people with Metabolic Syndrome, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT Angiography Plaque (time frame: baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.