NCT01631838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

June 26, 2012

Last Update Submit

December 19, 2013

Conditions

Metabolic SyndromePlatelet Aggregation, Spontaneous

Keywords

TocotrienolsPlatelet aggregationMetabolic syndromePlatelet activationThrombosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Platelet activation

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

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

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

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

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

  • Lipid Profile

    Day 0 - fasting, Day 14 - fasting

  • D-dimer

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

  • +1 more secondary outcomes

Study Arms (2)

Tocotrienol-rich fraction 400mg

EXPERIMENTAL
Dietary Supplement: Tocotrienol-rich fraction 400mg

Placebo

EXPERIMENTAL
Dietary Supplement: Placebo

Interventions

Tocotrienol-rich fraction 400mgDIETARY_SUPPLEMENT

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

Also known as: TOCOVID SupraBio 200mg
Tocotrienol-rich fraction 400mg
PlaceboDIETARY_SUPPLEMENT

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

Also known as: Palm Olein
Placebo

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysia Palm Oil Board

Kajang, Selangor, 43000, Malaysia

Location

MeSH Terms

Conditions

Metabolic SyndromePlatelet Aggregation, SpontaneousThrombosis

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Ju Yen Fu, PhD

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 29, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

October 1, 2013

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

MY(1)