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
Sponsored by
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
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
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
No
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
No
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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