Aged Garlic Extract Study
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2019 |
| First Submitted: | 02/25/2019 |
| Estimated Enrollment Submitted: | 02/27/2019 |
| First Posted: | 02/28/2019 |
| Last Update Submitted: | 06/07/2019 |
| Last Update Posted: | 06/10/2019 |
| Actual Study Start Date: | 11/30/2016 |
| Estimated Primary Completion Date: | 05/31/2019 |
| Estimated Study Completion Date: | 05/31/2019 |
Condition or disease
Intervention/treatment
Dietary Supplement: Aged Garlic Extract
Dietary Supplement: Placebo
Phase
Arm Groups
| 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. | Dietary Supplement: Aged Garlic Extract |
| 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 |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Change in coronary artery calcium (CAC) score [One year]
Secondary Outcome Measures
1. The changes in inflammatory biomarkers. [One Year]
2. The changes in Interleukin-6 (IL-6) [One Year]
3. The changes in inflammatory biomarkers. [One Year]
4. The changes in the microcirculation measured by Laser Doppler velocimetry [One Year]
5. Changes in Low Density Lipoprotein [One Year]
6. Changes in Triglycerides [One Year]
7. Changes in Cholesterol [One Year]
8. Changes in High Density Lipoprotein [One Year]
9. Changes in lipid profile [One Year]
10. Changes in blood sugar [One Year]
11. Changes in Blood pressure [One Year]
12. Changes in BMI [One Year]
