NCT03860350

Aged Garlic Extract Study

Aged Garlic Extract (Kyolic) Study at Lund University, Sweden

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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 on inflammatory biomarkers and microcirculation. It is a double blind placebo controlled study. The participants will ingest AGE during a period of one year. The CAC will be controlled by computer tomography (CT) scan; the inflammatory biomarkers through blood sample test and the microcirculation through laser speckel imagining and laser doppler before and after the one year period of AGE ingestion.

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.

Conditions

• Coronary Artery Disease
• Microcirculation
• Biomarkers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Aged Garlic Extract
DIETARY_SUPPLEMENT	Placebo

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2019-03-01
• Last updated: 2019-06-11

Locations

1 site across 1 country: Sweden