Type 2 Diabetes Mellitus (DM)Phase 2NCT07888426
Tolerability and Safety of Nano-Tocotrienols
A Phase 2 study testing Nano-tocotrienols in people with Type 2 Diabetes Mellitus (DM), run by University of Malaya at 1 site in Malaysia.
Trial summary
The goal of this randomised controlled trial is to determine the long term safety and tolerability of nano-tocotrienols (50 - 400 mg/day for 6-months duration) to be used as a health supplement in both healthy individuals and those with Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (DM)
- What is being tested?
- Nano-tocotrienols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults ≥18 yrs old ≤60 yrs old (inclusive)
- Weight within the BMI of 18-35 kg/m2 (inclusive)
- Be willing and able to participate in all scheduled visits including follow-up, treatment plan, laboratory tests and other study procedures according to clinical protocol
- Able to provide written informed consent
Who cannot join
- Currently pregnant or on breast feeding
- Receiving other investigational drugs and vitamin E
- Existing ischaemic heart disease, symptomatic heart failure, stroke or peripheral arterial disease/amputation and/or uncontrolled concurrent illness within three (3 months) of study randomization
- Current or prior history of either HIV, Hepatitis B, or Hepatitis C infection
- Transaminitis defined by a raised ALT or AST >3 times upper limit normal
- Chronic kidney disease defined by either an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 or urinary albumin:creatinine ratio >3 mg/mmol with two (2) samples for three (3) consecutive months
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- A history of significant adverse reactions or allergies to any medications.
- Clinically significant medical history, physical examination findings or laboratory abnormalities at the investigators' discretion.
- Recent participation (within 28 days or 10 half-lives of the drug before dosing, whichever is longer) in other clinical study involving a marketed or investigational drug
- Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications
- Smoker ≥ 10 sticks of cigarettes a day, vape ≥ 20 mg of liquid nicotine a day, or equivalent.
- History of alcohol intake (≥ 14 units per week) within 6 months before dosing (1 unit of alcohol equals approximately ½ pint [285 mL] of beer, 1 glass [125 mL] of wine, or 1 shot [25 mL] of spirit).
- Active cancer in the last 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Universiti Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Lee Ling Lim, FRCP (London), +60379494422, limleeling@um.edu.my
Lee Ling Lim, FRCP (London)
About this study
Official title: Pilot Clinical Study on the Tolerability and Safety of Nano-Tocotrienols
The goal of this randomised controlled trial is to determine the long term safety and tolerability of nano-tocotrienols (50 - 400 mg/day for 6-months duration) to be used as a health supplement in both healthy individuals and those with Type 2 diabetes mellitus. The study will compare patients (both healthy and individuals with Type 2 diabetes mellitus) receiving placebo and those receiving nano-tocotrienols. They would then be followed up at 3 months and 6 months intervals to determine if there is any adverse events experienced with the supplement.
Read the detailed description
This study aims to determine the long term safety and tolerability of nano-tocotrienols (50 - 400 mg/day for 6-months duration) to be used as a health supplement in both healthy individuals and those with Type 2 diabetes mellitus. This is a parallel, double-blinded, randomized, placebo-controlled trial. Patients (both healthy and individuals with Type 2 diabetes mellitus) would be randomly distributed into 6 groups, with each group having 30 participants each. Patients would then be randomised into either receiving placebo liquid, low dose liquid nano-tocotrienols (50mg/day), high dose liquid nano-tocotrienols (400mg/day); or placebo powder, low dose powder nano-tocotrienols (50mg/day), high dose powder nano tocotrienols (400mg/day). They would then be followed up at 3 months and 6 months intervals to determine if there is any adverse events experienced with the supplement, and with blood test to evaluate safety and effect on different aspects of body health.
- Conditions
- Type 2 Diabetes Mellitus (DM)
- Being tested
- Nano-tocotrienols, Placebo
- Keywords
- nano-tocotrienols, Type 2 Diabetes Mellitus, safety, tolerability
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-tocotrienolsDrug
Pt will be given nano-tocotrienols, either in liquid or powder form, at either 50mg/day or 400mg/day for duration of 24 weeks
PlaceboDrug
Placebo, either in powder or liquid form
| Study group | Role | What they receive |
|---|---|---|
| Placebo liquid (sachet without nano-tocotrienols) | Placebo comparator | Placebo liquid Receives: Drug: Placebo |
| Low dose liquid nano-tocotrienols (50 mg/day) | Experimental | Low dose liquid nano-tocotrienols (50 mg/day) Receives: Drug: Nano-tocotrienols |
| High dose liquid nano-tocotrienols (400 mg/day) | Experimental | High dose liquid nano-tocotrienols (400 mg/day) Receives: Drug: Nano-tocotrienols |
| Placebo powder (sachet without nano-tocotrienols) | Placebo comparator | Placebo powder (sachet without nano-tocotrienols) Receives: Drug: Placebo |
| Low dose powder nano-tocotrienols (50 mg/day) | Experimental | Low dose powder nano-tocotrienols (50 mg/day) Receives: Drug: Nano-tocotrienols |
| High dose powder nano-tocotrienols (400 mg/day) | Experimental | High dose powder nano-tocotrienols (400 mg/day) Receives: Drug: Nano-tocotrienols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of events where safety biomarkers fall out of clinically acceptable ranges
Definition of clinically abnormal ranges:
- renal function: eGFR < 60 mL/min/1.73m2 or worsening of urine albumin:creatinine ratio by ≥30%
- liver function: AST or ALT > 3 times the upper limit of normal
- full blood count: presence of new-onset thrombocytopaenia (platelet count <150 x 109)
- Coagulation profile: presence of new-onset deranged PT, aPTT, or INR
- blood pressure: uncontrolled hypertension, measured in duplicates during clinic visits, with readings persistently >180/110 mmHg
Measured: From enrollment to 24 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (DM)Studies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Responsible party
- Sponsor
- Investigators
- Lee Ling Lim, FRCP (London), Principal investigator, Universiti Malaya Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888426
- Sponsor's protocol ID
- 2026223-16380
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Study on the Tolerability and Safety of Nano-Tocotrienols
- ClinicalTrials.gov ID
- NCT07888426
- Acronym / sponsor ID
- 2026223-16380
- Conditions
- Type 2 Diabetes Mellitus (DM)
- Keywords
- nano-tocotrienols, Type 2 Diabetes Mellitus, safety, tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 22 Oct 2026 (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 goal of this randomised controlled trial is to determine the long term safety and tolerability of nano-tocotrienols (50 - 400 mg/day for 6-months duration) to be used as a health supplement in both healthy individuals and those with Type 2 diabetes mellitus. The study will compare patients (both healthy and individuals with Type 2 diabetes mellitus) receiving placebo and those receiving nano-tocotrienols. They would then be followed up at 3 months and 6 months intervals to determine if there is any adverse events experienced with the supplement.
Detailed description
This study aims to determine the long term safety and tolerability of nano-tocotrienols (50 - 400 mg/day for 6-months duration) to be used as a health supplement in both healthy individuals and those with Type 2 diabetes mellitus. This is a parallel, double-blinded, randomized, placebo-controlled trial. Patients (both healthy and individuals with Type 2 diabetes mellitus) would be randomly distributed into 6 groups, with each group having 30 participants each. Patients would then be randomised into either receiving placebo liquid, low dose liquid nano-tocotrienols (50mg/day), high dose liquid nano-tocotrienols (400mg/day); or placebo powder, low dose powder nano-tocotrienols (50mg/day), high dose powder nano tocotrienols (400mg/day). They would then be followed up at 3 months and 6 months intervals to determine if there is any adverse events experienced with the supplement, and with blood test to evaluate safety and effect on different aspects of body health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo liquid (sachet without nano-tocotrienols) | Placebo comparator | Drug: PlaceboPlacebo liquid |
| Low dose liquid nano-tocotrienols (50 mg/day) | Experimental | Drug: Nano-tocotrienolsLow dose liquid nano-tocotrienols (50 mg/day) |
| High dose liquid nano-tocotrienols (400 mg/day) | Experimental | Drug: Nano-tocotrienolsHigh dose liquid nano-tocotrienols (400 mg/day) |
| Placebo powder (sachet without nano-tocotrienols) | Placebo comparator | Drug: PlaceboPlacebo powder (sachet without nano-tocotrienols) |
| Low dose powder nano-tocotrienols (50 mg/day) | Experimental | Drug: Nano-tocotrienolsLow dose powder nano-tocotrienols (50 mg/day) |
| High dose powder nano-tocotrienols (400 mg/day) | Experimental | Drug: Nano-tocotrienolsHigh dose powder nano-tocotrienols (400 mg/day) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults ≥18 yrs old ≤60 yrs old (inclusive)
- Weight within the BMI of 18-35 kg/m2 (inclusive)
- Be willing and able to participate in all scheduled visits including follow-up, treatment plan, laboratory tests and other study procedures according to clinical protocol
- Able to provide written informed consent
Key exclusion criteria (13 listed)
- Currently pregnant or on breast feeding
- Receiving other investigational drugs and vitamin E
- Existing ischaemic heart disease, symptomatic heart failure, stroke or peripheral arterial disease/amputation and/or uncontrolled concurrent illness within three (3 months) of study randomization
- Current or prior history of either HIV, Hepatitis B, or Hepatitis C infection
- Transaminitis defined by a raised ALT or AST >3 times upper limit normal
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 |
|---|---|---|
| Nano-tocotrienolsPt will be given nano-tocotrienols, either in liquid or powder form, at either 50mg/day or 400mg/day for duration of 24 weeks | Drug | High dose liquid nano-tocotrienols (400 mg/day), High dose powder nano-tocotrienols (400 mg/day), Low dose liquid nano-tocotrienols (50 mg/day), Low dose powder nano-tocotrienols (50 mg/day) |
| PlaceboPlacebo, either in powder or liquid form | Drug | Placebo liquid (sachet without nano-tocotrienols), Placebo powder (sachet without nano-tocotrienols) |
Primary outcome
Number of events where safety biomarkers fall out of clinically acceptable ranges
Time frame: From enrollment to 24 weeks from enrollment
Definition of clinically abnormal ranges: 1. renal function: eGFR < 60 mL/min/1.73m2 or worsening of urine albumin:creatinine ratio by ≥30% 2. liver function: AST or ALT > 3 times the upper limit of normal 3. full blood count: presence of new-onset thrombocytopaenia (platelet count <150 x 109) 4. Coagulation profile: presence of new-onset deranged PT, aPTT, or INR 5. blood pressure: uncontrolled hypertension, measured in duplicates during clinic visits, with readings persistently >180/110 mmHg
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Lee Ling Lim, FRCP (London) principal investigator
Universiti Malaya Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nano-tocotrienols in people with Type 2 Diabetes Mellitus (DM), run by University of Malaya 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 13 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: opening soon, as of the sponsor's last update on 22 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Ling Lim, FRCP (London) (+60379492868, limleeling@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of events where safety biomarkers fall out of clinically acceptable ranges (time frame: From enrollment to 24 weeks from enrollment). 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 22 Oct 2026.