Asians such as Malaysians, Indonesians, Thais, Chinese and Indians have been consuming tocotrienols from palm oil for almost 5000 years as these population use palm oil as their daily cooking oil. The daily average consumption of palm oil among Malaysians is about 30-50g per day, which is equivalent to approximately 25-35mg of pure full spectrum tocotrienol complex (alpha, beta, gamma and delta-tocotrienol) per day.
Toxicological and pharmacological studies have shown that palm tocotrienol complex is safe even at extremely high dosage. Oo et al. shows that rats fed with 2500mg pure tocotrienols per kg of body weight per day with no adverse side effects [1].
In another study, Japanese researchers show that the No-Observed- Adverse-Effect Level (NOAEL) for tocotrienols is 120mg/kg body weight/day for male rats whereas female rats is 130mg /kg body weight/day [2].
Bio-enhanced palm tocotrienol complex has been used in many clinical trials (as shown Table 2) with various doses of tocotrienols that have been well-tolerated in humans. All the published clinical studies below have no reporting of adverse events for daily dosage up to 400mg for the duration of up to 2 years.
| Year | Study | Number of study subjects | Duration | Dosage of Bio-enhanced palm T3 complex |
Indication | Adverse Events |
| 2015 | Potential of Mixed Tocotrienol Supplementation to Reduce Cholesterol and Cytokines Level in Adults with Metabolic Syndrome (Hui-Ling Che, et al., 2015) | 70 | 16 weeks | 200mg
(Twice a day) |
Metabolic Syndrome | No adverse events reported |
| 2015 | Validation of a HPLC/FLD Method for Quantification of Tocotrienols in Human Plasma (Heng KS, et.al., 2015) | 3 | 14 days | 200mg
(Twice a day) |
Tocotrienols Level in Blood Plasma | No adverse events reported |
| 2014 | Clinical investigation of the protective effects of palm vitamin E tocotrienols on brain white matter (Gopalan Y, et al., 2014) | 121 | 2 years | 200mg of (Twice a day) | Brain Health | No adverse events reported |
| 2013 | The effect of vitamin E (mixed tocotrienol) on the liver stiffness measurement measured by transient elastography (FibroScan) among NAFLD patients (Arguillas M, et al., June 7th, 2013) |
67 | 3 months | 100mg daily | Liver Health | No adverse events reported |
| 2013 | Tocotrienols for normalization of hepatic echogenic response in nonalcoholic fatty liver: a randomized placebo-controlled clinical trial (Magosso E, et al., 2013) | 87 | 1 year | 200mg of (Twice a day) | Liver Health | No adverse events reported |
| 2012 | Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients (Patel V, et al., 2012) | 64 | 12 weeks | 200mg of (Twice a day) | Liver Health | No adverse events reported |
| 2011 | Effects of mixed-tocotrienols in hypercholesterolemic subjects (KH Yuen et al., 2011) |
32 | 6 months | 300mg daily | Heart Health | No adverse events reported |
| 2010 | Effects of tocotrienol supplementation on hair growth in human volunteers (Lim AB, et al, 2010) | 38 | 8 months | 50mg of (Twice a day) | Hair Health | No adverse events reported |
| 2008 | Arterial compliance and vitamin E blood levels with a self-emulsifying preparation of tocotrienol rich vitamin E (Rasool, AHG et al., 2008) | 36 | 2 months | 50,100, & 200mg daily | Heart Health | No adverse events reported |
| 2007 | Comparative study of the effect of tocotrienols and alpha-tocopherol on fasting serum lipid profiles (Ajuluchukwu JN, et al, 2007) | 44 | 4 weeks | 50mg | Heart Health | No adverse events reported |
| 2007 | US PTO – Tocotrienols and Hair Growth Formulation (Ho D, et al., 2007) | 19 | 5 months | 50mg (Twice a day) |
Hair Health | No adverse events reported |
| 2006 | Postprandial levels of the natural vitamin E tocotrienol in human circulation (Khosla P, et al, 2006) | 4 | Single dose of administration | 400mg | Tocotrienols Level in Blood Plasma | No adverse events reported |
References:
- Oo, S.L., P.Chang and K.E.Chan (1992). Toxicological and pharmacological studies on palm vitee. Nutr.Res., 12:S217-S222.
- Nakamura, H, et.al (2001). Oral toxicity of a tocotrienol preparation in rats. Food and Chemical Toxicology, 39 (8), 799-805.