The Effect of Mastiha Oil in Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Change in insulin sensitivity
研究概览
简要总结
Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Over 90 compounds have been identified in Mastiha oil, with monoterpenes exhibiting favorable effects in regulating mechanisms of oxidative stress and inflammation. The aim of this study is to determine the effect of Mastiha oil in adults with Metabolic Syndrome. 90 participants will be allocated to two groups, (45 in intervention group and 45 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.
The effects of the intervention will be evaluated via clinical and laboratory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 years < Age < 75 years
- •Metabolic Syndrome cardiometabolic parameters
- •A stable weight for ≥ 3 months pre-intervention
- •An unchanged treatment regimen for ≥ 6 months pre-intervention
排除标准
- •Hepatotoxic Medication
- •Untreated Diabetes Mellitus
- •Dysthyroidism, hypopituitarism, Cushing syndrome / disease
- •Pregnancy, lactation
- •Psychiatric or mental disorder
- •Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, anti-, pre- or pro-biotics within 3 months pre-intervention
结局指标
主要结局
Change in insulin sensitivity
时间窗: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood LDL
时间窗: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood total cholesterol
时间窗: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
Change in blood triglycerides
时间窗: 3 months
Levels will be evaluated pre and prost intervention in both control and intervention groups
次要结局
- Change in blood CRP(3 months)
- Change in blood IL-6(3 months)
- Change in blood MPO(3 months)
- Change in blood antioxidant potential(3 months)
研究者
Andriana C Kaliora
Associate Professor in Foods and Human Nutrition
Harokopio University