Status:
COMPLETED
Aged Garlic Extract Study
Lead Sponsor:
Lund University Hospital
Conditions:
Coronary Artery Disease
Microcirculation
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The primary intention of the study is to examine the effect of aged garlic extract (AGE) on the absolute change in coronary artery calcium (CAC). The second intention is to examine the effect of AGE o...
Detailed Description
Objectives: Effect on coronary artery atherosclerosis / the progression of atherosclerosis Effect on inflammatory and oxidation biomarkers Cholesterol lowering effect Effect on microcirculation Type...
Eligibility Criteria
Inclusion
- CAC score \>10
- Framingham risk score (10 % or above)
- Subjects are required to be on stable concomitant medications for at least 12 weeks prior to randomization
- Subjects with diabetic must have HbA1C \< 8.0, and stable HbA1C level variation range within 0.5% for three months.
Exclusion
- Hypersensitivity to AGE therapy,
- Unstable medical, psychiatric, or substance abuse disorder that may interfere with continuation in the study,
- Weight ≥325 pounds,
- Bleeding disorder,
- History of myocardial infarction,
- Stroke
- Life-threatening arrhythmia within prior 6 months,
- Resting hypotension (systolic \< 90 mmHg) or hypertension (resting blood pressure \>170/110)
- Heart failure NYHA class III or IV,
- 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 baseline visit
- Diabetic subjects with HbA1C \> 8 %,
- Drug or alcohol abuse
- Conditions interfering with accurate assessment of coronary calcification (metal clips, bypass patients, intracoronary stents) and drug absorption (partial ileal bypass or malabsorption syndrome).
- Current use of anticoagulants (except for antiplatelet agents)
- Chronic renal failure
- Liver failure
- Hematological or biochemical values at baseline visit outside the reference ranges considered as clinically significant.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03860350
Start Date
December 1 2016
End Date
June 1 2019
Last Update
June 11 2019
Active Locations (1)
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1
Skane University Hospital
Lund, Sweden, 22241