Metabolic Syndrome, Platelet Aggregation, Spontaneous
Conditions
Keywords
Tocotrienols, Platelet aggregation, Metabolic syndrome, Platelet activation, Thrombosis
Brief 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.
Interventions
DIETARY_SUPPLEMENTTocotrienol-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_SUPPLEMENTPlacebo
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
Sponsors
Universiti Putra Malaysia
Malaysia Palm Oil Board
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 25-60 year * Haemoglobin level \>11.5 g/dL in women and \>12.5 g/dL in men * Serum ferritin \> 15µg/L * According to Clinical Practice Guidelines, Management of Type 2 Diabetes Mellitus in Malaysia (2009), metabolic syndrome subjects are identified with: * Waist circumference ≥ 90 cm in men and ≥ 80 cm in women and with any two of the following criteria: * Elevated triacylglycerols \> 1.7 mmol/L * Low HDL cholesterol \< 1.0 mmol/L in men and \< 1.3 mmol/L in women * Elevated blood pressure ≥ 130/≥85 mm Hg * Fasting glucose ≥ 5.6 mmol/L to 7 mmol/L
Exclusion criteria
* Medical history of myocardial infarction, angina, ischemic attack, hemorrhagic stroke, deep vein thrombosis, coronary artery disease, bleeding disorder, cancer, allergy to vitamin E * Smoker * Lactose intolerance * Pregnancy or lactation * Current use of vitamin E, medications modulating blood coagulation, hypertension, lipid-lowering and glucose-lowering agents, corticosteroids * Significant hepatic and renal impairment * Fever, cold or infection during bleeding day * Alcoholic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet Aggregation | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr | Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemostatic markers (Plasminogen activator inhibitor type 1 and sP-selectin) | Day 0 - fasting, Day 14 - fasting, Day 14 - 2hr, Day 14 - 4hr, Day 14 - 6 hr | Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions |
| Inflammatory markers (sE-selectin, sICAM-1, and sVCAM-1) | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr | Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions |
| Platelet activation | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr | Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr. |
| D-dimer | Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr | Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions |
| Full blood count and liver function test | Day 0-fasting and Day 14-fasting | Comparison will be made between Day 14-fasting |
| Lipid Profile | Day 0 - fasting, Day 14 - fasting | Comparison will be made between Day 14-fasting |
Countries
Malaysia
Outcome results
None listed