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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Platelet Aggregation, Spontaneous
• Interventions: Dietary Supplement: Tocotrienol-rich fraction 400mg; Dietary Supplement: Placebo

• Registration Number: NCT01631838
• Lead Sponsor: Malaysia Palm Oil Board

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Primary Completion: 2012-08
• Study Completion: 2013-10
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tocotrienol-rich fraction 400mg	Tocotrienol-rich fraction 400mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Lipid Profile	Day 0 - fasting, Day 14 - fasting	Comparison will be made between Day 14-fasting
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
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.

Trial Locations

Locations (1)

Malaysia Palm Oil Board; 🇲🇾 Kajang, Selangor, Malaysia