Metabolic SyndromeNCT01631838
Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
A study testing Tocotrienol-rich fraction 400mg in people with Metabolic Syndrome and Platelet Aggregation, Spontaneous, run by Malaysia Palm Oil Board at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Metabolic Syndrome, Platelet Aggregation, Spontaneous
- What is being tested?
- Tocotrienol-rich fraction 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- May 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Tocotrienol-rich fraction 400mg, Placebo
- Keywords
- Tocotrienols, Platelet aggregation, Metabolic syndrome, Platelet activation, Thrombosis
- Medical subject headings
- Metabolic Syndrome, Platelet Aggregation, Spontaneous, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienol-rich fraction 400mgDietary supplement
Also called TOCOVID SupraBio 200mg
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
PlaceboDietary supplement
Also called Palm Olein
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
| Study group | Role | What they receive |
|---|---|---|
| Tocotrienol-rich fraction 400mg | Experimental | Not described Receives: Dietary Supplement: Tocotrienol-rich fraction 400mg |
| Placebo | Experimental | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Aggregation
Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.
Measured: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Secondary outcomes (6)
Platelet activation
Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.
Measured: Day 0 - fasting, Day 14 - fasting, Day 14 - 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
Measured: 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)
Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions
Measured: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Lipid Profile
Comparison will be made between Day 14-fasting
Measured: Day 0 - fasting, Day 14 - fasting
D-dimer
Comparison will be made between Day 14-fasting and postprandial response will be compared between two interventions
Measured: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Full blood count and liver function test
Comparison will be made between Day 14-fasting
Measured: Day 0-fasting and Day 14-fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Sponsor
- Investigators
- Ju Yen Fu, PhD, Principal investigator, Malaysia Palm Oil Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631838
- Sponsor's protocol ID
- PD157/11
- Status last verified
- Dec 2013
- First submitted
- 26 Jun 2012
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tocotrienols Supplementation on Platelet Aggregation in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01631838
- Acronym / sponsor ID
- PD157/11
- Keywords
- Tocotrienols, Platelet aggregation, Metabolic syndrome, Platelet activation, Thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- Universiti Putra Malaysia
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocotrienol-rich fraction 400mg | Experimental | Dietary Supplement: Tocotrienol-rich fraction 400mg |
| Placebo | Experimental | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocotrienol-rich fraction 400mgAlso: TOCOVID SupraBio 200mgTocovid 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 | Dietary supplement | Tocotrienol-rich fraction 400mg |
| PlaceboAlso: Palm OleinPlacebo 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 | Dietary supplement | Placebo |
Primary outcome
Platelet Aggregation
Time frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Comparison will be made between Day 14-fasting and changes will be measured between Day 14-fasting and 4hr.
6 secondary outcomes
Platelet activation
Time frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 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
Inflammatory markers (sE-selectin, sICAM-1, and sVCAM-1)
Time frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Lipid Profile
Time frame: Day 0 - fasting, Day 14 - fasting
D-dimer
Time frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr
Full blood count and liver function test
Time frame: Day 0-fasting and Day 14-fasting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju Yen Fu, PhD principal investigator
Malaysia Palm Oil Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocotrienol-rich fraction 400mg in people with Metabolic Syndrome and Platelet Aggregation, Spontaneous, run by Malaysia Palm Oil Board at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Aggregation (time frame: Day 0 - fasting, Day 14 - fasting, Day 14 - 4hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.