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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
Sponsor:
Collaborator:
Universiti Putra Malaysia
Information provided by (Responsible Party):
Malaysia Palm Oil Board

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Platelet Aggregation, Spontaneous Dietary Supplement: Tocotrienol-rich fraction 400mg Dietary Supplement: Placebo Not Applicable

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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Malaysia
Malaysia Palm Oil Board
Kajang, Selangor, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
Universiti Putra Malaysia
Investigators
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Principal Investigator: Ju Yen Fu, PhD Malaysia Palm Oil Board
More Information
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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
Keywords provided by Malaysia Palm Oil Board:
Tocotrienols
Platelet aggregation
Metabolic syndrome
Platelet activation
Thrombosis
Additional relevant MeSH terms:
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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
Nutrients
Growth Substances