InflammationINTOCNCT03532763
Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
A study testing Tocotrienol-rich fraction in people with Inflammation and Cardiovascular Risk Factor, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
The objective of this study is to address the anti-inflammatory effect of tocotrienol supplementation in subjects with moderately elevated inflammation. It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory markers of subjects. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Inflammation, Cardiovascular Risk Factor
- What is being tested?
- Tocotrienol-rich fraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Apr 2018to 30 Jun 2019
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30-60
- Elevated plasma hs-CRP level of > 1 mg/L < 10 mg/L
Who cannot join
- Subjects with very high LDL-cholesterol ≥ 4.9 mmol/L
- Subjects with very high hs-CRP level ≥ 10 mg/L
- Pregnancy or lactation
- Current use of vitamin E or corticosteroids
- Significant hepatic and renal impairment
- Fever, cold or infection during bleeding day
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Malaysian Palm Oil Board
Kajang, Selangor, 43000
JU YEN FU, PhD
About this study
The objective of this study is to address the anti-inflammatory effect of tocotrienol supplementation in subjects with moderately elevated inflammation.
It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory markers of subjects.
Read the detailed description
A double-blind, randomized, placebo-controlled, parallel study comparing the effect of tocotrienols vs. placebo will be conducted in subjects with moderately elevated inflammation. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily or placebo for 6 months. Fasting blood samples will be collected at baseline, 3 months, 6 months. A post-study fasting blood sample will be collected at 9 months.
- Conditions
- Inflammation, Cardiovascular Risk Factor
- Being tested
- Tocotrienol-rich fraction, Placebo
- Keywords
- Inflammation, Tocotrienols, Cardiovascular disease
- Medical subject headings
- Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienol-rich fractionDietary supplement
Also called Tocovid Suprabio 200 mg
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction
PlaceboDietary supplement
1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein
| Study group | Role | What they receive |
|---|---|---|
| Tocotrienol-rich fraction | Experimental | Not described Receives: Dietary Supplement: Tocotrienol-rich fraction |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Change in high-sensitivity c-reactive protein (hs-CRP)
Measured: 0, 3, 6, 9 months
Secondary outcomes (4)
Inflammatory markers
Changes in IL-6, IL-1alpha, IL-1beta, TNF-alpha, E-selectin, ICAM-1, VCAM-1
Measured: 0, 3, 6, 9 months
Thrombotic markers
Changes in PAI-1, D-dimer
Measured: 0, 3, 6, 9 months
Lipid profile
Changes in TC, LDL, HDL, ApoA1, ApoB
Measured: 0, 3, 6, 9 months
Glucose homeostasis
Changes in Glucose, insulin, c-peptide
Measured: 0, 3, 6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start19 Apr 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Parallel groups
- Model description
- Randomized, double blind, placebo-controlled, parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532763
- Sponsor's protocol ID
- 28701
- Acronym
- INTOC
- Status last verified
- Aug 2018
- First submitted
- 26 Apr 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Effect of Tocotrienol Supplementation in Subjects With Moderately Elevated Inflammation
- ClinicalTrials.gov ID
- NCT03532763
- Acronym / sponsor ID
- INTOC / 28701
- Conditions
- Inflammation, Cardiovascular Risk Factor
- Keywords
- Inflammation, Tocotrienols, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- Universiti Putra Malaysia
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 22 May 2018 (actual)
- 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-inflammatory effect of tocotrienol supplementation in subjects with moderately elevated inflammation.
It is hypothesized that 6 months supplementation of tocotrienols will reduce inflammatory markers of subjects.
Detailed description
A double-blind, randomized, placebo-controlled, parallel study comparing the effect of tocotrienols vs. placebo will be conducted in subjects with moderately elevated inflammation. Subjects will be supplemented with Tocovid Suprabio 200 mg twice daily or placebo for 6 months. Fasting blood samples will be collected at baseline, 3 months, 6 months. A post-study fasting blood sample will be collected at 9 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo-controlled, parallel
| Arm | Type | Receives |
|---|---|---|
| Tocotrienol-rich fraction | Experimental | Dietary Supplement: Tocotrienol-rich fraction |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 30-60
- Elevated plasma hs-CRP level of > 1 mg/L < 10 mg/L
Key exclusion criteria (6 listed)
- Subjects with very high LDL-cholesterol ≥ 4.9 mmol/L
- Subjects with very high hs-CRP level ≥ 10 mg/L
- Pregnancy or lactation
- Current use of vitamin E or corticosteroids
- Significant hepatic and renal impairment
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 fractionAlso: Tocovid Suprabio 200 mg1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction | Dietary supplement | Tocotrienol-rich fraction |
| Placebo1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein | Dietary supplement | Placebo |
Primary outcome
Inflammation
Time frame: 0, 3, 6, 9 months
Change in high-sensitivity c-reactive protein (hs-CRP)
4 secondary outcomes
Inflammatory markers
Time frame: 0, 3, 6, 9 months
Thrombotic markers
Time frame: 0, 3, 6, 9 months
Lipid profile
Time frame: 0, 3, 6, 9 months
Glucose homeostasis
Time frame: 0, 3, 6, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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.
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 in people with Inflammation and Cardiovascular Risk Factor, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JU YEN FU, PhD (+60126392394, fujuyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation (time frame: 0, 3, 6, 9 months). 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 29 Aug 2018.