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

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


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Metabolic Syndrome Vitamin E

Drug Information available for: Vitamin E Tocopherol

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

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

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


Malaysia
Malaysia Palm Oil Board
Kajang, Selangor, Malaysia, 43000

Sponsors and Collaborators

Malaysia Palm Oil Board

Universiti Putra Malaysia

Investigators


Principal Investigator:	Ju Yen Fu, PhD	Malaysia Palm Oil Board

More Information


Responsible Party:	Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:	NCT01631838 History of Changes
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:


Syndrome Metabolic Syndrome X Blood Platelet Disorders Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Hematologic Diseases	Tocotrienols Vitamin E Tocopherols Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances

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