NCT01631838

Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Malaysia Palm Oil Board · Other Government
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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. It is hypothesized that 2 weeks supplementation of tocotrienols will be able to suppress platelet aggregation in subjects with metabolic syndrome.

Detailed description

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.

Conditions

• Metabolic Syndrome
• Platelet Aggregation, Spontaneous

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tocotrienol-rich fraction 400mg	Tocovid Suprabio 200mg is taken twice daily (after breakfast and dinner) for 2 weeks. During postprandial day (Day 14), subjects are requested to consume breakfast meal containing 50g of fat and 100mL of milkshake, follow by capsule consumption
DIETARY_SUPPLEMENT	Placebo	Placebo is taken twice daily (after breakfast and dinner) for 2 weeks. During postprandial day (Day 14), subjects are requested to consume breakfast meal containing 50g of fat and 100mL of milkshake, follow by capsule consumption

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-08-01
• Completion: 2013-10-01
• First posted: 2012-06-29
• Last updated: 2013-12-20

Locations

1 site across 1 country: Malaysia