Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Inflammation
研究概览
简要总结
The objective of this study is to address the anti-inflammatory effect of tocotrienol supplementation in subjects with moderately elevated inflammation.
It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory markers of subjects.
详细描述
A double-blind, randomized, placebo-controlled, parallel study comparing the effect of tocotrienols vs. placebo will be conducted in subjects with moderately elevated inflammation. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily or placebo for 6 months. Fasting blood samples will be collected at baseline, 3 months, 6 months. A post-study fasting blood sample will be collected at 9 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-60
- •Elevated plasma hs-CRP level of > 1 mg/L < 10 mg/L
排除标准
- •Subjects with very high LDL-cholesterol ≥ 4.9 mmol/L
- •Subjects with very high hs-CRP level ≥ 10 mg/L
- •Pregnancy or lactation
- •Current use of vitamin E or corticosteroids
- •Significant hepatic and renal impairment
- •Fever, cold or infection during bleeding day
研究组 & 干预措施
Tocotrienol-rich fraction
干预措施: Tocotrienol-rich fraction (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Inflammation
时间窗: 0, 3, 6, 9 months
Change in high-sensitivity c-reactive protein (hs-CRP)
次要结局
- Inflammatory markers(0, 3, 6, 9 months)
- Thrombotic markers(0, 3, 6, 9 months)
- Lipid profile(0, 3, 6, 9 months)
- Glucose homeostasis(0, 3, 6, 9 months)