A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change in blood triglycerides
研究概览
简要总结
Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 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 Hypetriglyceridemia 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
研究组 & 干预措施
Intervention group
Participants with hypetriglyceridemia will be subjected to nutritional counsel and the intake of 1 soft gel capsule daily for a total of 3 months.
干预措施: MastihaOil (Dietary Supplement)
Control group
Participants with hypetriglyceridemia will be subjected to nutritional counsel for a total of 3 months.
干预措施: nutritional counsel (Behavioral)
结局指标
主要结局
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
未报告次要终点
研究者
Andriana C Kaliora
Associate Professor in Foods and Human Nutrition
Harokopio University