Toxicology

tocotrienol-source

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:

  1. Oo, S.L., P.Chang and K.E.Chan (1992). Toxicological and pharmacological studies on palm vitee. Nutr.Res., 12:S217-S222.
  2. Nakamura, H, et.al (2001). Oral toxicity of a tocotrienol preparation in rats. Food and Chemical Toxicology, 39 (8), 799-805.