Effect of Retinoic Acid Supplementation on the HDL-Associated Paraoxonase 1 Activity in Subjects With Hypercholesterolemia: A Randomized, Double-Blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- PON1 activity
研究概览
简要总结
The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity and cholesterol efflux capacity in hypercholesterolemic subjects.
详细描述
Paraoxonase 1 (PON1), an enzyme associated with high-density lipoprotein, is reported to have antioxidant and cardioprotective properties. And all-trans-retinoic acid revealed the ameliorating atherosclerosis effects in many reports.There maybe some correlations between retinoic acid and PON1 activity and the study aim to prove it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject has a fasting total cholesterol concentration between 200 and 310mg/dl.
- •subject is between 25 and 65 years of age, inclusive.
- •subjects' BMI is between 18.5 kg/m2 and 35 kg/m2.
排除标准
- •subject that is pregnant.
- •subject that has coronafy artery desease, diabetes mellitus, thyroid disorders, mental disorder, cancer, cirrhosis, renal disease and hepatic desease.
- •subject that has had operation less than six months prior to screening visit.
- •subject that is smoking.
- •subject uses any drugs that could influence the measurement of lipid paramerters or inflammatiory makers.
结局指标
主要结局
PON1 activity
时间窗: changes from baseline in PON1 activity at 12 weeks
PON1 activity is assayed in HDL isolated from plasma of subjects from the placebo and retinoic acid groups by using UV spectrophotometry in a 96-well plate format using phenyl acetate or paraoxon as substrates.
次要结局
- Lp-PLA2 activity(changes from baseline in Lp-PLA2 activity at 12 weeks)
研究者
Di Li
Doctor of Medicine
Sun Yat-sen University