A Phase 2 interventional study of Nano-tocotrienols and Placebo in Type 2 Diabetes Mellitus (DM), sponsored by University of Malaya. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Malaya · Phase 2, Interventional, and Other
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 360 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Malaya is the lead sponsor of 282 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Placebo liquid
Drug: Placebo
Low dose liquid nano-tocotrienols (50 mg/day)
Drug: Nano-tocotrienols
High dose liquid nano-tocotrienols (400 mg/day)
Drug: Nano-tocotrienols
Placebo powder (sachet without nano-tocotrienols)
Drug: Placebo
Low dose powder nano-tocotrienols (50 mg/day)
Drug: Nano-tocotrienols
High dose powder nano-tocotrienols (400 mg/day)
Drug: Nano-tocotrienols
Pt will be given nano-tocotrienols, either in liquid or powder form, at either 50mg/day or 400mg/day for duration of 24 weeks
Placebo, either in powder or liquid form
Number of events where safety biomarkers fall out of clinically acceptable ranges
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
Time frame: From enrollment to 24 weeks from enrollment
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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