Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT01631838 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Last Update Posted : December 20, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome Platelet Aggregation, Spontaneous | Dietary Supplement: Tocotrienol-rich fraction 400mg Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Tocotrienol-rich fraction 400mg |
Dietary Supplement: 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
Other Name: TOCOVID SupraBio 200mg |
Experimental: Placebo |
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
Other Name: Palm Olein |
- 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.
- 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.
- 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
- 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
- Lipid Profile [ Time Frame: Day 0 - fasting, Day 14 - fasting ]Comparison will be made between Day 14-fasting
- 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
- Full blood count and liver function test [ Time Frame: Day 0-fasting and Day 14-fasting ]Comparison will be made between Day 14-fasting

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Ages Eligible for Study: | 25 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631838
Malaysia | |
Malaysia Palm Oil Board | |
Kajang, Selangor, Malaysia, 43000 |
Principal Investigator: | Ju Yen Fu, PhD | Malaysia Palm Oil Board |
Responsible Party: | Malaysia Palm Oil Board |
ClinicalTrials.gov Identifier: | NCT01631838 |
Other Study ID Numbers: |
PD157/11 |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | December 20, 2013 |
Last Verified: | December 2013 |
Tocotrienols Platelet aggregation Metabolic syndrome Platelet activation Thrombosis |
Metabolic Syndrome Syndrome Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Tocotrienols |
Vitamin E Tocopherols Tocovid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients |