The Impact of Artichoke Leaf Extract on Blood Cholesterol: Primary Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Concentrations of High Density Lipoprotein Cholesterol
研究概览
简要总结
Pycrinil® is a purified extract of the artichoke leaf. Artichoke leaf extract (ALE) has some clinical trial data suggesting benefit in the treatment of cholesterol disorders in several countries, but this effect has not been studied in a U.S. population. The investigators will give ALE or a placebo to overweight men and women with low "good" cholesterol to see if ALE increases their good cholesterol. The investigators will also make sure that ALE is safe.
详细描述
Subjects will be divided into one of two groups: (1) Pycrinil®/flaxseed oil or (2) Placebo/flaxseed oil twice daily with food. The two formulations will be identical in appearance and standardized by Indena, S.p.A. Patients will be enrolled for a total of 3 months (± 1 week to allow for scheduling flexibility) with a 1 month (± 1 week to allow for scheduling flexibility) first follow-up visit in between enrollment and final visits. At all visits, patients will be asked to monitor for any symptomatic ADE. The first follow-up visit will focus on medication compliance (via pill count) and safety assessment (including laboratories). The final study visit will consist of brief clinical assessment (including anthropometrics), completed lifestyle and physical activity assessments, subjective ADE reporting, and donated blood and urine for clinical laboratory tests. Medication changes are not prohibited during the study period, but must be recorded. Medication bottles will be collected at the first follow-up and final visits; pill counts will be performed to assess compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •HDL cholesterol <40 mg/dL in men or <50 mg/dL in women
- •BMI ≥25 kg/m2.
排除标准
- •Patient on statins
- •Triglycerides >400 mg/dL
- •Low density lipoprotein (LDL) >190 mg/dL
- •Significant hepatic disease (i.e., documented diagnosis of hepatic cancer, hepatitis, or cirrhosis)
- •Significant renal disease (i.e., most recent glomerular filtration rate <30 mL/min/1.73 m2)
- •Significant gastrointestinal tract disease (documented diagnosis of malabsorption disorder, GI cancer, or uncontrolled inflammatory bowel disease)
- •History of transplant
- •Women of reproductive potential not receiving birth control
- •Pregnant/nursing women
结局指标
主要结局
Change in Concentrations of High Density Lipoprotein Cholesterol
时间窗: 3 months
次要结局
未报告次要终点
研究者
Daniel Riche
Associate Professor
University of Mississippi Medical Center