Hadley, Massachusetts (July 15, 2020) – Delta-tocotrienol from annatto decreased biomarkers associated with fatty liver and improved steatosis, suggests a published clinical study in patients diagnosed with NAFLD.
A recent study conducted at the Armed Forces Institute of Pathology in Pakistan, published in Complementary Therapies in Medicine, adds further data to the existing body of evidence that shows tocotrienol benefits for the liver. Results of the 24-week randomized, double-blind, placebo-controlled trial of the patented DeltaGold® annatto-derived tocotrienol ingredient by American River Nutrition indicate significant efficacy on liver-related biomarkers, fatty liver index and HOMA-IR scores, while decreasing the degree of hepatic steatosis in NAFLD patients. This is a continuation of a previously published 12-week clinical trial, and independently confirms the longer-term benefits of tocopherol-free tocotrienol in NAFLD.
In the 24-week study of 71 NAFLD patients, DeltaGold tocotrienol was administered at a dosage of 600mg/day (300mg twice daily), which led to decreased biochemical levels and metabolic factors associated with fatty liver, and improved steatosis. This was compared to a blinded and placebo group. All patients were advised a lifestyle modification of regular physical activity and reduced fat and carb diet.
Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is stored in the liver, and is most commonly associated with obesity and metabolic syndrome. According to the Mayo Clinic, NAFLD affects approximately 80-100 million US adults, and can transition to the more serious non-alcoholic steatohepatitis (NASH). The American Liver Foundation estimates that about 30 million Americans progress to NASH. Complications of the disease include liver fibrosis, cirrhosis, and liver cancer, with irreversible cases requiring liver transplants. Currently, there is no pharmacological treatment for NAFLD, and changes in exercise and diet are the standard of care. Natural alternatives are highly sought after to provide safe and effective treatment for NAFLD.
Both the 12-week and 24-week trials included measurements of serum aminotransferases (ALT, AST) and gamma-glutamyl transferase (GGT), while inflammatory high-sensitivity C-reactive protein (hs-CRP), oxidative stress marker malondialdehyde (MDA), and triglycerides were also tested. Physical measures included weight, body mass index (BMI) and waist circumference. The Fatty Liver Index (FLI), which includes measures of weight, BMI, waist circumference, GGT, and triglycerides, was used to predict liver fat storage.
In addition, the 24-week study looked at changes in interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha), leptin, and adiponectin, and tested patients for hepatic steatosis severity via ultrasonography. The study also assessed the gold standard of insulin resistance using the homeostatic model assessment of insulin resistance (HOMA-IR) calculation.
Continued improvements in biomarkers of hepatic stress reduction were evident after 24 weeks, with decreases of 18-21% in ALT and AST. Furthermore, significant decreases in triglycerides (13%), MDA (19%), and hs-CRP (21%) were indicative of additional reductions in inflammation compared to the 12-week results. Similarly, the FLI score decreased 15% as compared to 11% at 12 weeks, pointing to continued intrahepatic fat reduction over time. This is further supported by the remarkable observation that during the 12-week treatment period, patients in the tocotrienol-supplemented group lost an average of 9.7 pounds, whereas weight loss increased to 14.9 pounds after 24 weeks.
The longer treatment period of 24 weeks allowed for additional measurements, notably the grading of hepatic steatosis severity by ultrasonography. Following the treatment period, there were 10 patients with a 1 degree reduction and one patient with a 2 degree reduction in hepatic steatosis. In the placebo group, only 4 patients showed a 1 degree reduction in hepatic steatosis attributable to lifestyle changes.
Examining metabolic syndrome risk factors, other measurements at 24 weeks included HOMA-IR, adiponectin, and leptin. HOMA-IR, a calculation that marks for the presence and extent of insulin resistance, was reduced by 15% in the tocotrienol group. Both adiponectin and leptin are hormones that are critically secreted by adipose tissue. Adiponectin regulates glucose levels and fatty acid breakdown, whereas leptin can be pro-angiogenic, pro-inflammatory, and chronically elevated in obesity. In the tocotrienol group, adiponectin levels increased by an astonishing 44%, whereas leptin decreased by 18%. In comparison, adiponectin in the placebo group increased by only 3%, with leptin decreasing 3%. IL-6 and TNF-alpha, also thought to be major inflammatory mediators of both NAFLD and insulin resistance, were reduced by 24% and 21%, respectively, in the tocotrienol group.
The authors noted that “delta-tocotrienol supplementation for 24 weeks effectively improved biochemical markers of hepatocellular injury and steatosis in patients with NAFLD,” further remarking that “delta-tocotrienol might be considered as a therapeutic option in the management of patients with NAFLD.”
Commenting on the research, Dr. Barrie Tan, President of American River Nutrition said that “while the earlier 12-week study already suggested significant benefits of DeltaGold® for NAFLD patients, we now have evidence of a compelling duration-response benefit of tocotrienol to liver health.” Tan points at the obvious weight loss and ultrasonography findings as strong proof of DeltaGold®’s effect. Adds Tan, “Doctors currently recommend alpha-tocopherol supplementation for NAFLD patients in an effort to reduce oxidative stress, but we think that tocotrienol will be much more powerful and will go further to help. This is the subject of an ongoing 12-month clinical trial, which will compare the effects of alpha-tocopherol versus DeltaGold® in NAFLD patients, and we look forward to sharing those results soon.”
Vitamin E is a family of eight separate but related molecules: four tocopherols (alpha, beta, gamma, delta) and four tocotrienols (alpha, beta, gamma, delta). While alpha-tocopherol is found in most multivitamins and is supplemented in foods, a growing base of evidence suggests that this popular vitamin E interferes with the uptake and function of tocotrienols. Tocotrienols are derived from three major sources, including annatto, palm, and rice.
Source: Complementary Therapies in Medicine
Delta-tocotrienol supplementation improves biochemical markers of hepatocellular injury and steatosis in patients with nonalcoholic fatty liver disease: A randomized, placebo-controlled trial.
Authors: Pervez MA, Khan DA, Slehria AUR, Ijaz A.
About American River Nutrition
American River Nutrition, founded in 1998, is the producer of DeltaGold® tocotrienols, the most beneficial form of vitamin E for cardiovascular health, as well as other health benefits. The company is led by Dr. Barrie Tan, a pioneering scientist and researcher credited with identifying the primary sources of plant-based tocotrienols, including rice, palm & the virtually 100% tocotrienol-producing annatto plant. American River products are manufactured in the U.S. using a proprietary process leading to the purest form of natural tocotrienols available.
View Clinical Trial Here.