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

Malaysia Palm Oil Board

Status

Completed

Conditions

Platelet Aggregation, Spontaneous

Metabolic Syndrome

Treatments

Dietary Supplement: Tocotrienol-rich fraction 400mg

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01631838

PD157/11

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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