A recent study conducted at the Armed Forces Institute of Pathology in Pakistan, published in the Turkish Journal of Gastroenterology, added new data to a growing body of evidence that showed tocotrienol benefits for the liver. Results of the 12-week randomized, double-blind, placebo-controlled trial of the patented DeltaGold annatto-derived tocotrienol ingredient by American River Nutrition, Inc. indicated significant efficacy on the fatty liver index score and other liver-related biomarkers in NAFLD patients. This is the first-ever clinical trial using tocotrienols only (without the presence of tocopherols) in NAFLD, according to American River.
In the 12-week study of 71 NAFLD patients, DeltaGold tocotrienol was administered at a dosage of 600 mg/day (300 mg twice daily), which led to decreased biochemical levels and metabolic factors associated with fatty liver. This was compared to a blinded and placebo group. All patients were advised to eat a fat-reduced diet and perform regular physical activity.
NAFLD occurs when excess fat is stored in the liver, and is most commonly associated with obesity and metabolic syndrome. According to the National Institute of Health, NAFLD is estimated to affect 30-40% of U.S. adults, and can transition to the more serious non-alcoholic steatohepatits (NASH) in 20% of these cases. Complications of the disease include liver fibrosis, cirrhosis, and liver cancer, with progressive cases requiring liver transplants. Currently, there is no pharmacological treatment for NAFLD, and changes in diet and exercise are the standard of care. Natural alternatives may provide safe and effective treatment for NAFLD.
Liver biomarkers that were examined included 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 for predicting fatty liver.
Significant improvements in liver biomarkers indicative of hepatic stress reduction were evident after 12 weeks, with decreases of 15-16% in ALT, AST. Furthermore, significant decreases in triglycerides (11%), MDA (14%), and hs-CRP (18%) were indicative of reduced inflammation and are consistent with results of previous clinical trials conducted with DeltaGold in hypercholesterolemic subjects. Notably, the FLI score decreased a significant 11%, suggesting intrahepatic fat reduction. During the 12-week treatment period, patients in the tocotrienol-supplemented group lost an average of 9.7 pounds. Although ultrasonography was utilized to assess the degree of liver steatosis at the beginning and end of the intervention, the study duration was too short to allow for the extent of intrahepatic fat reduction necessary for radiological detection. FLI, on the other hand, based on biochemical and anthropometric measures, is more sensitive than ultrasonography for detecting therapy response during short intervals.
The authors noted that the study outcomes were very encouraging, providing a platform for future larger-scale clinical trials. They remarked that “these results provide a proof-of-principle for the superiority of delta-tocotrienol, and strongly favor the safe and effective use of this compound for the management of NAFLD in the future.”
Commenting on the research, Dr. Barrie Tan, president of American River Nutrition Inc. said that “delta-tocotrienol’s anti-inflammatory effect—including remarkable decreases in hs-CRP—has now been best indicated in clinical trials for hyperlipidemia, osteopenia, and NAFLD, where annatto tocotrienol consistently reduced inflammation.” Dr. Tan believes this is the first tocotrienol study to show an almost 10-pound weight loss in NAFLD patients, a phenomenon previously undocumented for the supplement. “I look forward to future trials that will further explore the effects of annatto tocotrienol on NAFLD patients, with a larger population, longer duration, and additional diagnostic tools.”
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 this popular vitamin E interferes with the uptake and function of tocotrienols. Tocotrienols are derived from three major sources, including rice, palm and annatto.