Safety of nano-tocotrienol supplements in healthy adults and adults with type 2 diabetes
Tests nano-tocotrienol supplements against placebo in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Tolerability and Safety of Nano-Tocotrienols
Key facts
- Where
- Kuala Lumpur, MalaysiaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07888426, who can take part
Where in Malaysia
- Universiti Malaya Medical CentreKuala Lumpur, MalaysiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Malaya
- Trial code
- NCT07888426
- Record updated
- 22 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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); A history of significant adverse reactions or allergies to any medications; Active cancer in the last 5 years; 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; Clinically significant medical history, physical examination findings or laboratory abnormalities at the investigators' discretion; Currently pregnant or on breast feeding; Smoker ≥ 10 sticks of cigarettes a day, vape ≥ 20 mg of liquid nicotine a day, or equivalent.