Aged Garlic Extract (Kyolic) Study at Lund University, Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in coronary artery calcium (CAC) score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,
- •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.
研究组 & 干预措施
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.
干预措施: Placebo (Dietary Supplement)
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.
干预措施: Aged Garlic Extract (Dietary Supplement)
结局指标
主要结局
Change in coronary artery calcium (CAC) score
时间窗: 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.
次要结局
- The changes in the microcirculation measured by Laser Doppler velocimetry(One Year)
- Changes in Low Density Lipoprotein(One Year)
- Changes in Triglycerides(One Year)
- Changes in High Density Lipoprotein(One Year)
- Changes in BMI(One Year)
- The changes in Interleukin-6 (IL-6)(One Year)
- Changes in lipid profile(One Year)
- Changes in blood sugar(One Year)
- Changes in Cholesterol(One Year)
- Changes in Blood pressure(One Year)
- The changes in inflammatory biomarkers.(One Year)
研究者
Sandra Lindstedt Ingemansson
Senior Consultant and Associate Professor
Lund University Hospital