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

Primary Purpose

Metabolic Syndrome, Platelet Aggregation, Spontaneous

Status

Completed

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Tocotrienol-rich fraction 400mg

Placebo

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring Tocotrienols, Platelet aggregation, Metabolic syndrome, Platelet activation, Thrombosis

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Malaysia Palm Oil Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tocotrienol-rich fraction 400mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Platelet Aggregation

Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.

Secondary Outcome Measures

Platelet activation

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)

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)

Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions

Lipid Profile

Comparison will be made between Day 14-fasting

D-dimer

Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions

Full blood count and liver function test

Comparison will be made between Day 14-fasting

Full Information

NCT ID

NCT01631838

First Posted

June 26, 2012

Last Updated

December 19, 2013

Sponsor

Malaysia Palm Oil Board

Collaborators

Universiti Putra Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT01631838

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Malaysia Palm Oil Board

Collaborators

Universiti Putra Malaysia

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome, Platelet Aggregation, Spontaneous

Keywords

Tocotrienols, Platelet aggregation, Metabolic syndrome, Platelet activation, Thrombosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tocotrienol-rich fraction 400mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Tocotrienol-rich fraction 400mg

Other Intervention Name(s)

TOCOVID SupraBio 200mg

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

Palm Olein

Intervention Description

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

Primary Outcome Measure Information:

Title

Platelet Aggregation

Description

Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.

Time Frame

Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr

Secondary Outcome Measure Information:

Title

Platelet activation

Description

Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.

Time Frame

Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr

Title

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

Description

Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions

Time Frame

Day 0 - fasting, Day 14 - fasting, Day 14 - 2hr, Day 14 - 4hr, Day 14 - 6 hr

Title

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

Description

Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions

Time Frame

Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr

Title

Lipid Profile

Description

Comparison will be made between Day 14-fasting

Time Frame

Day 0 - fasting, Day 14 - fasting

Title

D-dimer

Description

Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions

Time Frame

Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr

Title

Full blood count and liver function test

Description

Comparison will be made between Day 14-fasting

Time Frame

Day 0-fasting and Day 14-fasting

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ju Yen Fu, PhD

Organizational Affiliation

Malaysia Palm Oil Board

Official's Role

Principal Investigator

Facility Information:

Facility Name

Malaysia Palm Oil Board

City

Kajang

State/Province

Selangor

ZIP/Postal Code

43000

Country

Malaysia

12. IPD Sharing Statement

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

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