Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome (NCT01631838) | Clinical Trial Compass
CompletedNot Applicable
Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
Malaysia32 participantsStarted 2012-05
Plain-language 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.
Who can participate
Age range25 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Platelet Aggregation
Timeframe: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr