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.

Inclusion Criteria: 1. Adults ≥18 yrs old ≤60 yrs old (inclusive) 2. Weight within the BMI of 18-35 kg/m2 (inclusive) 3. 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 4. Able to provide written informed consent Exclusion Criteria: 1. Currently pregnant or on breast feeding 2. Receiving other investigational drugs and vitamin E 3. 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 4. Current or prior history of either HIV, Hepatitis B, or Hepatitis C infection 5. Transaminitis defined by a raised ALT or AST \>3 times upper limit normal 6. Chronic kidney disease defined by either an estimated glomerular filtration rate (eGFR) \3 mg/mmol with two (2) samples for three (3) consecutive months 7. A history of significant adverse reactions or allergies to any medications. 8. Clinically significant medical history, physical examination findings or laboratory abnormalities at the investigators' discretion. 9. 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 10. Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications 11. Smoker ≥ 10 sticks of cigarettes a day, vape ≥ 20 mg of liquid nicotine a day, or equivalent. 12. 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). 13. Active cancer in the last 5 years