AbsorptionNCT01185769
Study of Tocotrienol Absorption and Distribution Under Different Fat Status
A study testing Tocotrienol in people with Absorption, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans remains unclear especially with different fat diets.This study aimed at evaluating the absorption and distribution of tocotrienols in plasma and lipoproteins in associations with high and low fat diets. Read more about this study
- Who is it for?
- Ages 22 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Absorption
- What is being tested?
- Tocotrienol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMalaysia
- Study dates
- Sep 2009to Sep 2009
- 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 22 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male aged 22-25
- body mass index 18.5 < X < 30 kg/m2
- plasma cholesterol < 5.2 mmol/L,
- TAG < 1.7 mmol/L
Who cannot join
- history of cardiovascular disease
- diabetic
- body mass index < 18.5 or > 30 kg/m2
- plasma cholesterol > 5.2 mmol/L,
- TAG > 1.7 mmol/L
- hypertension
Show all 9Show fewer
- currently taking Vitamin E supplement
- current use of medication
- smoking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status
Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans remains unclear especially with different fat diets.This study aimed at evaluating the absorption and distribution of tocotrienols in plasma and lipoproteins in associations with high and low fat diets. Different fat level will affect the absorption and distribution of tocotrienols
Read the detailed description
There is a possibility that the absorption and distribution of tocotrienols may occur differently compared with tocopherols, especially under different fat status
- Conditions
- Absorption
- Being tested
- Tocotrienol
- Keywords
- Vitamin E, Absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocotrienolDietary supplement
500 mg of tocotrienol will be administered after consumption of high fat diet
TocotrienolDietary supplement
500 mg of tocotrienol will be administered after consumption of low fat diet
| Study group | Role | What they receive |
|---|---|---|
| High fat | Experimental | 500 mg of tocotrienol will be administered at single dose after consumption of high fat diet Receives: Dietary Supplement: Tocotrienol |
| Low fat | Experimental | 500 mg of tocotrienol will be administered at single dose after consumption of low fat diet Receives: Dietary Supplement: Tocotrienol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in absorption and distribution of Tocoterienols during high fat and low fat meal by measuring the plasma, chylomicron, and HDL level of tocotrienol
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbsorptionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- University of Malaya
- Investigators
- Weng-Yew Wong, Bsc, Principal investigator, Malaysia Palm Oil Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185769
- Sponsor's protocol ID
- PD141/09
- Status last verified
- Aug 2010
- First submitted
- 19 Aug 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status
- ClinicalTrials.gov ID
- NCT01185769
- Acronym / sponsor ID
- PD141/09
- Conditions
- Absorption
- Keywords
- Vitamin E, Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- University of Malaya
- Study start
- Sep 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Aug 2010 (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.
Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans remains unclear especially with different fat diets.This study aimed at evaluating the absorption and distribution of tocotrienols in plasma and lipoproteins in associations with high and low fat diets. Different fat level will affect the absorption and distribution of tocotrienols
Detailed description
There is a possibility that the absorption and distribution of tocotrienols may occur differently compared with tocopherols, especially under different fat status
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat | Experimental | Dietary Supplement: Tocotrienol500 mg of tocotrienol will be administered at single dose after consumption of high fat diet |
| Low fat | Experimental | Dietary Supplement: Tocotrienol500 mg of tocotrienol will be administered at single dose after consumption of low fat diet |
Who may qualify
- Ages
- 22 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male aged 22-25
- body mass index 18.5 < X < 30 kg/m2
- plasma cholesterol < 5.2 mmol/L,
- TAG < 1.7 mmol/L
Key exclusion criteria (9 listed)
- history of cardiovascular disease
- diabetic
- body mass index < 18.5 or > 30 kg/m2
- plasma cholesterol > 5.2 mmol/L,
- TAG > 1.7 mmol/L
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 |
|---|---|---|
| Tocotrienol500 mg of tocotrienol will be administered after consumption of high fat diet | Dietary supplement | High fat |
| Tocotrienol500 mg of tocotrienol will be administered after consumption of low fat diet | Dietary supplement | Low fat |
Primary outcome
Difference in absorption and distribution of Tocoterienols during high fat and low fat meal by measuring the plasma, chylomicron, and HDL level of tocotrienol
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal
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 Aug 2010.
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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.
Weng-Yew Wong, Bsc 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 in people with Absorption, 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 4 inclusion and 9 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 Aug 2010. 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?
Difference in absorption and distribution of Tocoterienols during high fat and low fat meal by measuring the plasma, chylomicron, and HDL level of tocotrienol (time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal). 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 Aug 2010.