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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631838
• Other study ID #: PD157/11
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: December 19, 2013
• Start date: May 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Platelet Aggregation, Spontaneous
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
Malaysia	Malaysia Palm Oil Board	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Aggregation	Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.	Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr	No
Secondary	Platelet activation	Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.	Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr	No
Secondary	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	Day 0 - fasting, Day 14 - fasting, Day 14 - 2hr, Day 14 - 4hr, Day 14 - 6 hr	No
Secondary	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	Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr	No
Secondary	Lipid Profile	Comparison will be made between Day 14-fasting	Day 0 - fasting, Day 14 - fasting	No
Secondary	D-dimer	Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions	Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr	No
Secondary	Full blood count and liver function test	Comparison will be made between Day 14-fasting	Day 0-fasting and Day 14-fasting	Yes