Clinical trial NCT01631838: Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
Official title: Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Platelet Aggregation, Spontaneous
Keywords: Tocotrienols
Platelet aggregation
Metabolic syndrome
Platelet activation
Thrombosis
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Putra Malaysia
First posted: 2012-06-29
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Platelet Aggregation
timeFrame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Secondary outcomes:
measure: Platelet activation
timeFrame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
measure: Haemostatic markers (Plasminogen activator inhibitor type 1 and sP-selectin)
timeFrame: Day 0 - fasting, Day 14 - fasting, Day 14 - 2hr, Day 14 - 4hr, Day 14 - 6 hr
measure: Inflammatory markers (sE-selectin, sICAM-1, and sVCAM-1)
timeFrame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
measure: Lipid Profile
timeFrame: Day 0 - fasting, Day 14 - fasting
measure: D-dimer
timeFrame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
measure: Full blood count and liver function test
timeFrame: Day 0-fasting and Day 14-fasting
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysia Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Ju Yen Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References: