Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inflammation
- Sponsor
- Malaysia Palm Oil Board
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Inflammation
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 30-60
- •Elevated plasma hs-CRP level of \> 1 mg/L \< 10 mg/L
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Inflammation
Time Frame: 0, 3, 6, 9 months
Change in high-sensitivity c-reactive protein (hs-CRP)
Secondary Outcomes
- 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)