Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers: a Prospective, Randomized, Placebo-controlled Study (MASTIHA-OIL Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- HDL cholesterol
研究概览
简要总结
A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.
详细描述
Background Chios Mastiha essential oil (CMO) is a natural product extracted from the resin of Mastiha, possessing antioxidant, anti-microbial, anti-ulcer,anti-neoplasmatic and cholesterol lowering capabilities in vitro, and its hypolipidemic effect was confirmed in animal studies. Yet, there are no randomized, placebo-controlled clinical studies in the literature regarding CMO's hypolipidemic effects in humans.
Design A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.
Methods 192 healthy volunteers were screened and eventually 160 of them with total cholesterol> 200 mg/dl participated in the study. They were randomized with a 2:1 ratio of receiving CMO capsules (containing 200 mg mastiha oil per capsule) and placebo for a total of 8 weeks respectively. 113 patients received CMO and 47 were randomized in the control group, and all of them completed the follow-up period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Increased total cholesterol >200 mg/dl, in adult volunteers (≥18 years old) of any gender, not amenable or not willing to receive pharmaceutical therapy.
排除标准
- •Participation in any other study during the recruitment period
- •Contribution in the design or accomplishment of the study
- •Known cardiovascular disease (coronary artery disease, carotid artery disease, peripheral vascular disease, stroke, diabetes mellitus, aortic aneurysm)
- •Patients in high or very high risk of CVD according to SCORE2
- •Subjects amenable to pharmaceutical lipid-lowering regimens according to current guideline, or any other pharmaceutical regimen with hypolipidemic effects
结局指标
主要结局
HDL cholesterol
时间窗: 8 weeks
Increase in HDL cholesterol serum levels
Total cholesterol
时间窗: 8 weeks
Decrease in total cholesterol serum levels
LDL cholesterol
时间窗: 8 weeks
Decrease in LDL cholesterol serum levels
Triglycerides
时间窗: 8 weeks
Decrease in triglycerides serum levels
次要结局
- Inflammation markers(8 weeks)
- Electrolytes(8 weeks)
- Glucose(8 weeks)
- Liver tests(8 weeks)
- Renal tests(8 weeks)
研究者
Matthaios Didagelos
Cardiologist
AHEPA University Hospital