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

This study has been completed.
Sponsor:
Collaborator:
Universiti Putra Malaysia
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01631838
First received: June 26, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 Intervention
Metabolic Syndrome
Platelet Aggregation, Spontaneous
Dietary Supplement: Tocotrienol-rich fraction 400mg
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • Platelet Aggregation [ Time Frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Comparison will be made between Day 14-fasting

  • D-dimer [ Time Frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Comparison will be made between Day 14-fasting


Enrollment: 32
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Malaysian Palm Oil Board
  More Information

No publications provided

Responsible Party: Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT01631838     History of Changes
Other Study ID Numbers: PD157/11
Study First Received: June 26, 2012
Last Updated: December 19, 2013
Health Authority: Malaysia: Institutional Review Board

Keywords provided by Malaysia Palm Oil Board:
Tocotrienols
Platelet aggregation
Metabolic syndrome
Platelet activation
Thrombosis

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Tocopherols
Tocotrienols
Vitamin E
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamins

ClinicalTrials.gov processed this record on November 24, 2014