Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
This study is ongoing, but not recruiting participants.
Sponsor:
Malaysia Palm Oil Board
Collaborator:
Universiti Putra Malaysia
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01631838
First received: June 26, 2012
Last updated: September 27, 2012
Last verified: June 2012
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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: Tocotrienols-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 ]Changes will be measured in between Day 0 and Day 14-fasting, and 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 ]Changes will be measured in between Day 0 and Day 14-fasting, and Day 14-fasting and 4hr.
- Haemostatic markers (Activated factor VII and Plasminogen activator inhibitor type 1) [ Time Frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 2hr, Day 14 - 4hr, Day 14 - 6 hr ] [ Designated as safety issue: No ]Changes will be measured in between Day 0 and Day 14-fasting. During Day 14, changes of markers when compared to fasting sample will be measured at 2 hours, 4 hours, and 6 hours after high fat breakfast.
- Inflammatory markers (NF-kB, sICAM-1, and sVCAM-1) [ Time Frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr ] [ Designated as safety issue: No ]Changes will be measured in between Day 0 and Day 14-fasting, and Day 14-fasting and 4hr.
- Lipid Profile [ Time Frame: Day 0 - fasting, Day 14 - fasting ] [ Designated as safety issue: No ]Changes will be measured in between Day 0 and Day 14-fasting
- D-dimer [ Time Frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr ] [ Designated as safety issue: No ]Changes will be measured in between Day 0 and Day 14-fasting, and Day 14-fasting and 4hr.
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tocotrienols-rich fraction 400mg |
Dietary Supplement: Tocotrienols-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 30-60 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 ≥ 1.69 mmol/L
- Low HDL cholesterol < 1.04 mmol/L in men and < 1.29 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
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: | September 27, 2012 |
| 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 Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Tocotrienols Vitamin E Tocopherols |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013