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

NCT ID: NCT01631838

Last Updated: 2013-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-10-31

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.

Conditions

Metabolic Syndrome; Platelet Aggregation, Spontaneous

Keywords

Tocotrienols; Platelet aggregation; Metabolic syndrome; Platelet activation; Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Tocotrienol-rich fraction 400mg

Group Type: EXPERIMENTAL

Tocotrienol-rich fraction 400mg

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Tocotrienol-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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

TOCOVID SupraBio 200mg; Palm Olein

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: collaborator

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ju Yen Fu, PhD

Role: PRINCIPAL_INVESTIGATOR

Malaysia Palm Oil Board

Locations

Malaysia Palm Oil Board

Kajang, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

PD157/11

Identifier Type: -

Identifier Source: org_study_id