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Completed

NCT Number: NCT01631838

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

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaysia Palm Oil Board

Kajang, Selangor, 43000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocotrienol-rich fraction 400mg

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

Other names: TOCOVID SupraBio 200mg

Placebo

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

Other names: Palm Olein

Primary outcomes

  1. Platelet Aggregation

    Time frame: 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 outcomes

  1. Platelet activation

    Time frame: 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.

  2. Haemostatic markers (Plasminogen activator inhibitor type 1 and sP-selectin)

    Time frame: 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

  3. Inflammatory markers (sE-selectin, sICAM-1, and sVCAM-1)

    Time frame: 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

  4. Lipid Profile

    Time frame: Day 0 - fasting, Day 14 - fasting

    Comparison will be made between Day 14-fasting

  5. D-dimer

    Time frame: 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

  6. Full blood count and liver function test

    Time frame: Day 0-fasting and Day 14-fasting

    Comparison will be made between Day 14-fasting

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • Universiti Putra Malaysia

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 29, 2012
Registry last updated
Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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