Metabolic SyndromeNCT01626430
Acute Effects of Tocotrienols on Insulin Sensitivity and Metabolic Risk Markers in Individuals at Risk for Metabolic Syndrome
A study testing Gamma delta TRF in people with Metabolic Syndrome, run by Malaysia Palm Oil Board at 2 sites in Malaysia.
Trial summary
Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Gamma delta TRF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesMalaysia
- Study dates
- Jan 2012to Dec 2012
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 20-60 years
- BMI ≥ 25 kg/m2
- Elevated triacylglycerols ≥ 1.70 mmol/L
- Low HDL cholesterol < 1.04 mmol/L (men), < 1.30 mmol/L (women)
- Elevated blood pressure ≥ 130/ ≥ 85 mmHg
- Fasting plasma glucose ≥ 5.60 - 7.00 mmol/L
- Increased waist circumference ≥ 90 cm (men), ≥ 80 cm (women)
Who cannot join
- BMI ≤ 18.5 kg/m2
- Current use of antihypertensive or lipid lowering, insulin/glucose modulating medication
- Lactose/milk intolerance
- Alcohol intake exceeding a moderate intake (> 28 units per week)
- Smoker
- Pregnancy or lactation
- Fever, cold and infection during bleeding day
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Malaysia Palm Oil Board
Kajang, Selangor, 43000
Malaysian Palm Oil Board (MPOB)
Kajang, Selangor, 43000
About this study
Official title: Acute Effects of Tocotrienols on Insulinaemic and Inflammatory Responses in Metabolic Syndrome Subjects
Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
Read the detailed description
A randomised, double-blind, crossover trial will be undertaken to test the acute effects of supplementation of 200 mg, 400 mg gd-TRF vs. placebo. There are 3 occasions for subjects to attend during postprandial period and these occasions will be separated by at least one week. On the day preceding the postprandial high fat meal challenge, subjects will be asked to avoid food high in fat, alcohol, caffeine and taking part in any strenuous exercise. Subjects will be provided with a standardised low fat meal (containing < 10 g fat) on the day preceding the postprandial study days to consume as their evening meal. They will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10 pm. Fasting blood samples will be collected on the next day and subjects will then consume the test meal, containing 50 g test fat supplemented with gd-TRF. Further venous blood samples will be collected at regular intervals for up to 6 hours postprandially.
- Conditions
- Metabolic Syndrome
- Being tested
- Gamma delta TRF, Placebo
- Keywords
- Gamma delta TRF, Insulin sensitivity, Postprandial lipaemia, Inflammatory markers, NF-κB
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma delta TRFDietary supplement
50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.
PlaceboDietary supplement
50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.
| Study group | Role | What they receive |
|---|---|---|
| 200 mg gd-TRF | Experimental | Not described Receives: Dietary Supplement: Gamma delta TRF |
| 400 mg gd-TRF | Experimental | Not described Receives: Dietary Supplement: Gamma delta TRF |
| 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.
C-peptide
Measured: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Secondary outcomes (5)
Insulin sensitivity (insulin, glucose)
Measured: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Non-esterified fatty acid (NEFA)
Measured: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Serum triglycerides (TAG)
Measured: 0, 60, 120, 180, 240, 300, 360 min
Inflammatory markers (IL-6, IL-1β, TNF-α)
Measured: 0, 120, 240, 360 min
PBMC nuclear factor-κappa B (NF-κB)
Measured: 0, 240, 360 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionDec 2012
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- Dr Teng Kim Tiu, PhD, Principal investigator, Malaysia Palm Oil Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626430
- Sponsor's protocol ID
- A004/11
- Status last verified
- Oct 2015
- First submitted
- 16 Jun 2012
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Tocotrienols on Insulinaemic and Inflammatory Responses in Metabolic Syndrome Subjects
- ClinicalTrials.gov ID
- NCT01626430
- Acronym / sponsor ID
- A004/11
- Conditions
- Metabolic Syndrome
- Keywords
- Gamma delta TRF, Insulin sensitivity, Postprandial lipaemia, Inflammatory markers, NF-κB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- University of Malaya
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 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.
Objectives: To compare the acute effects of gamma delta rich tocotrienol fractions (gd-TRF) on insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
Hypothesis: Gamma delta-rich TRF will improve insulin sensitivity, metabolic risk markers and postprandial lipemia in individuals at risk for metabolic syndrome.
Detailed description
A randomised, double-blind, crossover trial will be undertaken to test the acute effects of supplementation of 200 mg, 400 mg gd-TRF vs. placebo. There are 3 occasions for subjects to attend during postprandial period and these occasions will be separated by at least one week. On the day preceding the postprandial high fat meal challenge, subjects will be asked to avoid food high in fat, alcohol, caffeine and taking part in any strenuous exercise. Subjects will be provided with a standardised low fat meal (containing < 10 g fat) on the day preceding the postprandial study days to consume as their evening meal. They will be asked to fast overnight and instructed to avoid eating or drinking anything, except water, after 10 pm. Fasting blood samples will be collected on the next day and subjects will then consume the test meal, containing 50 g test fat supplemented with gd-TRF. Further venous blood samples will be collected at regular intervals for up to 6 hours postprandially.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200 mg gd-TRF | Experimental | Dietary Supplement: Gamma delta TRF |
| 400 mg gd-TRF | Experimental | Dietary Supplement: Gamma delta TRF |
| Placebo | Experimental | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 20-60 years
- BMI ≥ 25 kg/m2
- Elevated triacylglycerols ≥ 1.70 mmol/L
- Low HDL cholesterol < 1.04 mmol/L (men), < 1.30 mmol/L (women)
- Elevated blood pressure ≥ 130/ ≥ 85 mmHg
Key exclusion criteria (7 listed)
- BMI ≤ 18.5 kg/m2
- Current use of antihypertensive or lipid lowering, insulin/glucose modulating medication
- Lactose/milk intolerance
- Alcohol intake exceeding a moderate intake (> 28 units per week)
- Smoker
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 |
|---|---|---|
| Gamma delta TRF50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake. | Dietary supplement | 200 mg gd-TRF, 400 mg gd-TRF |
| Placebo50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake. | Dietary supplement | Placebo |
Primary outcome
C-peptide
Time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
5 secondary outcomes
Insulin sensitivity (insulin, glucose)
Time frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Non-esterified fatty acid (NEFA)
Time frame: 0, 5, 15, 30, 60, 90, 120, 180, 240, 300, 360 min
Serum triglycerides (TAG)
Time frame: 0, 60, 120, 180, 240, 300, 360 min
Inflammatory markers (IL-6, IL-1β, TNF-α)
Time frame: 0, 120, 240, 360 min
PBMC nuclear factor-κappa B (NF-κB)
Time frame: 0, 240, 360 min
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 7 Oct 2015.
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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.
Dr Teng Kim Tiu, PhD principal investigator
Malaysia Palm Oil Board
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma delta TRF in people with Metabolic Syndrome, run by Malaysia Palm Oil Board at 2 sites 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 7 inclusion and 7 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 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
C-peptide (time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300, 360 min). 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 7 Oct 2015.