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| Name | Class |
|---|---|
| Universiti Putra Malaysia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocotrienol-rich fraction 400mg | Experimental |
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| Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol-rich fraction 400mg | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Aggregation | Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr. | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet activation | Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr. | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr |
| Haemostatic markers (Plasminogen activator inhibitor type 1 and sP-selectin) |
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Inclusion Criteria:
and with any two of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ju Yen Fu, PhD | Malaysia Palm Oil Board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malaysia Palm Oil Board | Kajang | Selangor | 43000 | Malaysia |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| C566800 | Platelet Aggregation, Spontaneous |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Placebo | Dietary Supplement | 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 |
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Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions |
| Day 0 - fasting, Day 14 - fasting, Day 14 - 2hr, Day 14 - 4hr, Day 14 - 6 hr |
| Inflammatory markers (sE-selectin, sICAM-1, and sVCAM-1) | Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr |
| Lipid Profile | Comparison will be made between Day 14-fasting | Day 0 - fasting, Day 14 - fasting |
| D-dimer | Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr |
| Full blood count and liver function test | Comparison will be made between Day 14-fasting | Day 0-fasting and Day 14-fasting |
| D009750 |
| Nutritional and Metabolic Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |