The clinical trial led by Prof. Chandan K. Sen from the Ohio State University Medical Center is registered with the NIH’s Clinicaltrials.gov website. The primary objective was to determine the levels of vitamin E isomers in human tissues and vital organs following oral supplementation. Tocomin SupraBio^®, patented and bioenhanced natural full spectrum palm tocotrienol softgel (Carotech Inc.) was used.

A total of 80 human subjects were recruited. Blood samples and skin biopsies were obtained from a group of healthy participants who received 12 weeks of tocotrienols supplementation (400mg per day). Another group of subjects consists of surgical patients were randomized to receive either 400mg of tocotrienols or tocopherols daily. These surgical patients provided tissues samples of cardiac muscle, liver, abdominal adipose tissues, and brain tissues. The mean supplementation duration is 20 weeks, ranging from 1 to 96 weeks.

The researchers found that healthy subjects have negligible levels of tocotrienols in both blood and skin prior to tocotrienols supplementation. 12 weeks of Tocomin SupraBio^® supplementation significantly increased the tocotrienol levels in both blood and skin. In addition, the observed alpha-tocotrienol concentration in blood is 20-fold higher than that required to provide neuroprotection.

The adipose tissue in tocotrienol supplemented patients contains approximately 10 times the tocotrienol levels compared to controls. Tocotrienol supplementation also significantly increased alpha, gamma, and delta-tocotrienol levels in the human brain. Alpha-tocotrienol was transported to human brain at a concentration reported to be neuroprotective in earlier studies. In both heart muscle and liver – alpha, gamma, and delta-tocotrienol levels were significantly higher in tocotrienol supplemented patients as compared to subjects receiving tocopherol alone.

MELD scoring system is clinically used to assess the severity of chronic liver disease. The higher the MELD score, the more severe the condition and increases the urgency for liver transplantation.  MELD score is a reliable marker for mortality in end-stage liver disease. Over the period of the study, which was initially designed to look at tocotrienols levels in the explanted liver tissues, the researchers noticed that tocotrienols supplemented end stage liver disease patients experienced a reduction in their MELD scores. Among subjects supplemented with tocopherol alone, only 20% (1 out of 5) experienced lowering of MELD score. In contrast, 50% (7 out of 14) of the tocotrienol supplemented subjects showed MELD score improvement.

MELD score reduction by Tocomin SupraBio^® supplementation was most evident in patients with viral hepatic cirrhosis where 4 out of 6 patients (67%) with hepatitis C and the single hepatitis B patient had reduced MELD score. Although standard of care therapy is available for viral hepatitis, it is poorly tolerated due to its toxicity and side effects.

“It is very exciting to learn from this human study that oral supplementation of bioenhanced palm tocotrienol complex – Tocomin SupraBio^®, improves accumulation of tocotrienols in the blood, skin, adipose, brain, heart and liver. The study also shows that Tocomin SupraBio^® significantly lowered the MELD score in end stage liver disease patients.  and may therefore be an exciting oral supplement with potential to benefit these patients. Tocopherol again did not show the same level of efficacy,” says WH Leong, Vice President of Carotech Inc.

“This human study also proved that tocotrienols are absorbed and accumulated in vital human organs even in the presence of tocopherol, thereby unequivocally dispelling claims that tocopherol prevents the absorption of tocotrienols,” adds WH Leong.

Source:

The Journal of Nutrition, 2012 Feb 1. (Epub ahead of print)

“Oral Tocotrienols are Transported to Human Tissues and Delay the Progression of the Model for End-Stage Liver Disease Score in Patients”