Aged Garlic Extract Study (AGE)
|ClinicalTrials.gov Identifier: NCT03860350|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Microcirculation Biomarkers||Dietary Supplement: Aged Garlic Extract Dietary Supplement: Placebo||Not Applicable|
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.
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).
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind placebo controlled prospective study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Aged Garlic Extract (Kyolic) Study at Lund University, Sweden|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
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.
Dietary Supplement: Aged Garlic Extract
Other Name: Kyolic
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.
Dietary Supplement: Placebo
- 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.
- The changes in inflammatory biomarkers. [ Time Frame: One Year ]Changes in C-reactive protein (CRP mg/L)
- The changes in Interleukin-6 (IL-6) [ Time Frame: One Year ]Changes in IL-6 (ng/L)
- The changes in inflammatory biomarkers. [ Time Frame: One Year ]Changes in Homocystein (µmol/L)
- The changes in the microcirculation measured by Laser Doppler velocimetry [ Time Frame: One Year ]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.
- Changes in Low Density Lipoprotein [ Time Frame: One Year ]Changes of Low Density Lipoprotein (LDL) mmol/L
- Changes in Triglycerides [ Time Frame: One Year ]Changes of Triglycerides mmol/L.
- Changes in Cholesterol [ Time Frame: One Year ]Changes of cholesterol mmol/L.
- Changes in High Density Lipoprotein [ Time Frame: One Year ]Changes of High Density Lipoprotein(HDL) mmol/L,
- Changes in lipid profile [ Time Frame: One Year ]Apolipoprotein B (mmol/L)/Apolipoprotein A1 (mmol/L)
- Changes in blood sugar [ Time Frame: One Year ]Changes in fastening blood glucose measured as mmol/L
- Changes in Blood pressure [ Time Frame: One Year ]Changes of blood pressure Systolic and Diastolic presented as mmHg.
- Changes in BMI [ Time Frame: One Year ]Changes in BMI measured as weight (kg) and height (m) and will be combined to report BMI in kg/m^2
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860350
|Skane University Hospital|
|Lund, Sweden, 22241|
|Principal Investigator:||Sandra Lindstedt, MD, PhD||Skane University Hospital|