World's First Clinical Trial For Fatty Liver Treatment
The world’s first clinical trial for Non-Alcoholic Fatty Liver Disease (NAFLD) treatment using Tocotrienols is underway. If all goes well, the preliminary results will be out within six months from the commencement of the trial in February with a full publication of the findings in 2021.
Sime Darby Oils (SDO) and Universiti Kebangsaan Malaysia (UKM) are carrying out trials, and the collaboration may take two years.
A Memorandum of Agreement was signed on Feb 11, 2020, between SDO Managing Director Mohd Haris Mohd Arshad and UKM’s Dean of Faculty of Medicine and Professor of Medicine Dr Raja Affendi Raja Ali who represented UKM’s official signatory, Vice-Chancellor, Professor Datuk Ir. Dr Mohd Hamdi Abd Shukor.
The trial will determine if the palm oil derived NATRIEO Tocotrienols that plays the role as an antioxidant classified in vitamin E, could be used as a therapeutic
approach in treating NAFLD.
Dr Raja Affendi said they would berunning a randomised double-blind trial with a localised demographic sample focusing on full-spectrum testing of fatty liver,the first and the most comprehensive of its kind in the world.
NAFLD is one of the most common chronic liver diseases, ranging from non-alcoholic fatty liver (NAFL) to nonalcoholic steatohepatitis (NASH). NAFLD is an accumulation of excess fat in the liver. Primary stage of NAFLD will not cause any harm. But in the long run, it may lead to severe liver damage, including cirrhosis. Previous studies have shown that the prevalence of NAFLD was associated with dietary changes and lifestyle habits, such as exercise, smoking, having dinner within two hours of going to bed, specified sleeping and sitting duration.
The Tocotrienols to used in this first-ever clinical trial is a palm oil-derived natural form of vitamin E, extracted from palm fruit harvested by Sime Darby
Plantation (SDP). SDP pioneered the palm Tocotrienols extraction process in 1993 with the Malaysian Palm Oil Board (MPOB).
A Tocotrienol supplement called NATRIÉO produced by SDO has been made
commercially available by the company since 2002. This supplement will be used in carrying out the clinical trial.
Dr Raja Affendi added that vitaminE appears as a promising therapeutic
approach to treat fatty liver due to its antioxidant potency and antiinflammatory activity. “It has been shown to reduce oxidative stress in fatty liver. There are two forms of Vitamin E, tocopherol and Tocotrienols. The most widely studied Vitamin E is the tocopherol which is a saturated form of Vitamin E. Yet, Tocotrienols possesses dominant properties compared to tocopherol. Tocotrienols are neuroprotective besides being an antioxidant, anti-cancer and cholesterol-lowering. All these differ from tocopherol.
He further explained the unsaturated chain of Tocotrienols allows for better
penetration into tissue with saturated fatty layers, resulting in the preferential
distribution in the liver. The molecules are 40-60 times more potent in anti-oxidative properties than tocopherol. NATRIÉO, a natural product by SDO, is Tocotrienols -rich Vitamin E extracted 100% from local palm fruit.
Palm oil is one of the most abundant natural sources of Tocotrienols, with crude palm oil also known as the “Tocotrienolrich fraction”.
Mohd Haris said the Tocotrienols in NATRIÉO are extracted exclusively from
the Elaeis Guineesis species of oil palms grown in the Carey estate of their our
parent company, Sime Darby Plantation, the world’s largest producer of certified
sustainable palm oil.
He also highlighted that the molecular distillation process used in extracting Tocotrienols is a state-of-the-art process ensuring all impurities are removed from the oil while minimising degradation from heat and oxidation.
“With our ‘Source to Seal’ guarantee, we assure that our Tocotrienol extracted
from this process is of the highest quality and the freshest. The collaboration further solidifies our goal to be evidence-based in our claims, especially in the nutrition business,” he added
Source : The Health