Ongoing
Objective: The objective of this study is to address the anti-thrombotic effects of tocotrienols supplementation via modulation of platelet activation, thrombotic markers, inflammatory markers and endothelial function.
Study Type: Interventional
Study Design: Randomized, Double-blind
Subjects: Volunteers with metabolic syndrome
Intervention: Tocotrienol-rich fraction 400 mg, placebo
Primary Outcome: Platelet Aggregation. Changes will be measured in between Day 0 and Day 14-fasting, and Day 14-fasting and 4hr.
Secondary Outcome: 1) Platelet activation. Changes will be measured in between Day 0 and Day 14-fasting, and Day 14-fasting and 4hr.
2) Haemostatic markers (Activated factor VII and Plasminogen activator inhibitor type 1) Changes will be measured in between Day 0 and Day 14-fasting. During Day 14, changes of markers when compared to fasting sample will be measured at 2 hours, 4 hours, and 6 hours after high fat breakfast.
3) Inflammatory markers (NF-kB, sICAM-1, and sVCAM-1) Changes will be measured in between Day 0 and Day 14-fasting, and Day 14-fasting and 4hr.
4) Lipid Profile. Changes will be measured in between Day 0 and Day 14-fasting
5) D-dimer. Changes will be measured in between Day 0 and Day 14-fasting, and Day 14-fasting and 4hr.
Methodology: A double-blind, randomized, crossover study comparing the effects of tocotrienols vs. placebo will be conducted in subjects with metabolic syndrome. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily (or placebo) for 2 weeks followed by a postprandial challenge on Day 14. During the postprandial challenge, venous blood samples will be collected during fasting. Subjects are then required to consume a high fat breakfast meal containing 50g fat and 100mL milkshake, followed by the assigned capsules. Venous blood samples will be drawn at 2, 4 and 6 hours after consumption of capsules. A washout period of at least 14 days will be in place before the commencement of the second treatment.