- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860350
Aged Garlic Extract Study (AGE)
Aged Garlic Extract (Kyolic) Study at Lund University, Sweden
Study Overview
Status
Conditions
Intervention / Treatment
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 of study:
Randomized double blind controlled trial
Number of patients: 80 patients
Duration of the study:
The patients will be studied for one year after they have entered the study. The total time of the study duration from the including date of the first patient to the analysis of the last patient entering the study estimated to be 2-3 years. An inclusion rate off 1 to 2 patients per week.
Treatment:
Dose: Treated with a placebo capsule or a capsule containing a total of AGE 2400 mg daily for 1 year (2 Kyolic capsule (600 mg) twice daily).
Methods:
Placebo-controlled double blind randomized trial to determine whether AGE can influence the rate of atherosclerosis plaque burden measured by coronary artery calcium, improve vascular function and microcirculation and favorably change biomarkers of oxidative stress.
Randomization:
The participants are assigned to AGE or placebo in a double-blinded manner, using numbered containers assigned to a computer-generated randomization chart by a nurse coordinator.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lund, Sweden, 22241
- Skane University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aged Garlic Extract
The participants will ingest 600 mg of Aged Garlic Extract in two capsules two times a day i.e. 1200 mg/day during a period of one year.
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Other Names:
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Placebo Comparator: Placebo
The participants will ingest 600 mg of placebo in two capsules two times a day i.e. 1200 mg/day during a period of one year.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in coronary artery calcium (CAC) score
Time Frame: One year
|
CAC is to be defined as a plaque of at least three contiguous pixels (area 1.02 mm 2) with a density of > 130 Hounsfield units.
The lesion score are to be calculated by multiplying the lesion area by a density factor derived from the maximal Hounsfield unit within this area, as described by Agatston S, Janowitz WR, Hildner FJ et al.
Quantification of coronary artery calcium using ultrafast computed tomography.
J Am Coll Cardiol 1990; 15: 827-832.
CAC score is measured at baseline and after one year follow-up and the difference is calculated.
|
One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The changes in inflammatory biomarkers.
Time Frame: One Year
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Changes in C-reactive protein (CRP mg/L)
|
One Year
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The changes in Interleukin-6 (IL-6)
Time Frame: One Year
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Changes in IL-6 (ng/L)
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One Year
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The changes in inflammatory biomarkers.
Time Frame: One Year
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Changes in Homocystein (µmol/L)
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One Year
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The changes in the microcirculation measured by Laser Doppler velocimetry
Time Frame: One Year
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Laser Doppler Flowmetry (LDF) is a non-invasive method to estimate the blood perfusion in the microcirculation.
The advantage of the technique is that LDF provide a continuous or near continuous record of the microvascular blood flow.
No current laser Doppler instrument can present absolute perfusion values (e.g.
ml/min/100 gram tissue).
Measurements are expressed as perfusion units (PU) which are arbitrary.
The changes in PU will be measured.
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One Year
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Changes in Low Density Lipoprotein
Time Frame: One Year
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Changes of Low Density Lipoprotein (LDL) mmol/L
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One Year
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Changes in Triglycerides
Time Frame: One Year
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Changes of Triglycerides mmol/L.
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One Year
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Changes in Cholesterol
Time Frame: One Year
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Changes of cholesterol mmol/L.
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One Year
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Changes in High Density Lipoprotein
Time Frame: One Year
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Changes of High Density Lipoprotein(HDL) mmol/L,
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One Year
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Changes in lipid profile
Time Frame: One Year
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Apolipoprotein B (mmol/L)/Apolipoprotein A1 (mmol/L)
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One Year
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Changes in blood sugar
Time Frame: One Year
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Changes in fastening blood glucose measured as mmol/L
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One Year
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Changes in Blood pressure
Time Frame: One Year
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Changes of blood pressure Systolic and Diastolic presented as mmHg.
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One Year
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Changes in BMI
Time Frame: One Year
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Changes in BMI measured as weight (kg) and height (m) and will be combined to report BMI in kg/m^2
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One Year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sandra Lindstedt, MD, PhD, Skane University Hospital
Publications and helpful links
General Publications
- Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32. doi: 10.1016/0735-1097(90)90282-t.
- Lindstedt S, Malmsjo M, Hansson J, Hlebowicz J, Ingemansson R. Microvascular blood flow changes in the small intestinal wall during conventional negative pressure wound therapy and negative pressure wound therapy using a protective disc over the intestines in laparostomy. Ann Surg. 2012 Jan;255(1):171-5. doi: 10.1097/SLA.0b013e31823c9ffa.
- Lindstedt S, Malmsjo M, Hlebowicz J, Ingemansson R. Comparative study of the microvascular blood flow in the intestinal wall, wound contraction and fluid evacuation during negative pressure wound therapy in laparostomy using the V.A.C. abdominal dressing and the ABThera open abdomen negative pressure therapy system. Int Wound J. 2015 Feb;12(1):83-8. doi: 10.1111/iwj.12056. Epub 2013 Mar 21.
- Lindstedt S, Malmsjo M, Ingemansson R. No hypoperfusion is produced in the epicardium during application of myocardial topical negative pressure in a porcine model. J Cardiothorac Surg. 2007 Dec 6;2:53. doi: 10.1186/1749-8090-2-53.
- Lindstedt S, Malmsjo M, Ingemansson R. Blood flow changes in normal and ischemic myocardium during topically applied negative pressure. Ann Thorac Surg. 2007 Aug;84(2):568-73. doi: 10.1016/j.athoracsur.2007.02.066.
- Budoff MJ, Ahmadi N, Gul KM, Liu ST, Flores FR, Tiano J, Takasu J, Miller E, Tsimikas S. Aged garlic extract supplemented with B vitamins, folic acid and L-arginine retards the progression of subclinical atherosclerosis: a randomized clinical trial. Prev Med. 2009 Aug-Sep;49(2-3):101-7. doi: 10.1016/j.ypmed.2009.06.018. Epub 2009 Jun 30.
- Wlosinska M, Nilsson AC, Hlebowicz J, Fakhro M, Malmsjo M, Lindstedt S. Aged Garlic Extract Reduces IL-6: A Double-Blind Placebo-Controlled Trial in Females with a Low Risk of Cardiovascular Disease. Evid Based Complement Alternat Med. 2021 Mar 31;2021:6636875. doi: 10.1155/2021/6636875. eCollection 2021.
- Wlosinska M, Nilsson AC, Hlebowicz J, Hauggaard A, Kjellin M, Fakhro M, Lindstedt S. The effect of aged garlic extract on the atherosclerotic process - a randomized double-blind placebo-controlled trial. BMC Complement Med Ther. 2020 Apr 29;20(1):132. doi: 10.1186/s12906-020-02932-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DNR2016/745
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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