07.17.20
A clinical trial conducted at the Armed Forces Institute of Pathology in Pakistan published in the journal Complementary Therapies in Medicine, added to the existing body of evidence that tocotrienols benefit the liver. Tocotrienols (alpha, beta, gamma, and delta) are a branch of compounds in the vitamin E family, representing four of the eight forms, while the other four are known as tocopherols (also alpha, beta, gamma, and delta).
While alpha-tocopherol is most commonly used in multivitamins and food fortification, a growing base of evidence suggests that this form of vitamin E may interfere with the uptake and function of tocotrienols. Annatto, palm, and rice are the three main sources of tocotrienols.
The results of the 24-week randomized, double-blind, placebo-controlled trial of a patented annatto tocotrienol ingredient DeltaGold suggests that tocotrienols may be efficacious in delivering liver function benefits to patients with non-alcoholic fatty liver disease (NAFLD), a condition characterized by excess fat stores in the liver known to be a precursor for potentially fatal diseases including cirrhosis, liver fibrosis, and cancer.
Patients who were administered tocotrienols saw reduced biomarkers related to NAFLD, and additionally, they experienced significant improvements in fatty liver index and HOMA-IR scores compared to placebo. Tocotrienols also appeared to decrease the degree of hepatic steatosis in NAFLD patients.
This trial is a continuation of a previously-published 12-week study, which independently provided evidence that tocopherol-free tocotrienols can deliver long-term benefits to NAFLD patients.
71 NAFLD patients total were recruited for the trial, and DeltaGold tocotrienol was administered at a dosage of 300 mg twice daily. 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.
Both the 12-week and 24-week trials included measurements of serum aminotransferases (ALT and 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. The Fatty Liver Index was determined using measures of weight, BMI, waist circumference, GGT, and triglycerides.
The 24-week study also looked at changes in interleukin 6, tumor necrosis factor 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.
The experimental group saw decreases of 18-21% in ALT and AST, and significant decreases in triglycerides (13%), MDA (19%), and hs-CRP (21%) were also observed, indicating additional reductions in inflammation compared to the 12-week results. FLI score decreased 15% in the tocotrienol group compared to 11% in the placebo group at 12 weeks, pointing to continued intrahepatic fat reduction over time. This is further supported by the observation that the supplementation group lost an average of 9.7 pounds after 12 weeks, and an average of 14.9 pounds after 24 weeks.
Ten patients had one-degree reductions in hepatic steatosis, and one patient had a two-degree reduction, which was significantly better than the placebo group, in which only four patients experienced a one-degree reduction in hepatic steatosis attributable to lifestyle changes.
Insulin resistance, determined by measures of HOMA-IR, adiponectin, and leptin, was shown to be reduced by 15% in the tocotrienol group. Adiponectin and leptin are hormones that are critically secreted by adipose tissue. In the tocotrienol group, adiponectin levels increased by 44% and leptin decreased by 18%. In the placebo group, adiponectin levels increased by only 3% and leptin decreased by 3%.
The authors of the study concluded that “delta-tocotrienol supplementation for 24 weeks effectively improved biochemical markers of hepatocellular injury and steatosis in patiens with NAFLD,” and further, they remarked that “delta-tocotrienol might be considered as a therapeutic option in the management of patients with NAFLD.”
Dr. Barrie Tan, president of American River Nutrition, the makers of DeltaGold, said that the additional results coming from the 24 week study provided further substantiation of DeltaGold’s effect.
“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 said. “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 DeldaGold in NAFLD patients, and we look forward to sharing those results soon.
While alpha-tocopherol is most commonly used in multivitamins and food fortification, a growing base of evidence suggests that this form of vitamin E may interfere with the uptake and function of tocotrienols. Annatto, palm, and rice are the three main sources of tocotrienols.
The results of the 24-week randomized, double-blind, placebo-controlled trial of a patented annatto tocotrienol ingredient DeltaGold suggests that tocotrienols may be efficacious in delivering liver function benefits to patients with non-alcoholic fatty liver disease (NAFLD), a condition characterized by excess fat stores in the liver known to be a precursor for potentially fatal diseases including cirrhosis, liver fibrosis, and cancer.
Patients who were administered tocotrienols saw reduced biomarkers related to NAFLD, and additionally, they experienced significant improvements in fatty liver index and HOMA-IR scores compared to placebo. Tocotrienols also appeared to decrease the degree of hepatic steatosis in NAFLD patients.
This trial is a continuation of a previously-published 12-week study, which independently provided evidence that tocopherol-free tocotrienols can deliver long-term benefits to NAFLD patients.
71 NAFLD patients total were recruited for the trial, and DeltaGold tocotrienol was administered at a dosage of 300 mg twice daily. 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.
Both the 12-week and 24-week trials included measurements of serum aminotransferases (ALT and 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. The Fatty Liver Index was determined using measures of weight, BMI, waist circumference, GGT, and triglycerides.
The 24-week study also looked at changes in interleukin 6, tumor necrosis factor 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.
The experimental group saw decreases of 18-21% in ALT and AST, and significant decreases in triglycerides (13%), MDA (19%), and hs-CRP (21%) were also observed, indicating additional reductions in inflammation compared to the 12-week results. FLI score decreased 15% in the tocotrienol group compared to 11% in the placebo group at 12 weeks, pointing to continued intrahepatic fat reduction over time. This is further supported by the observation that the supplementation group lost an average of 9.7 pounds after 12 weeks, and an average of 14.9 pounds after 24 weeks.
Ten patients had one-degree reductions in hepatic steatosis, and one patient had a two-degree reduction, which was significantly better than the placebo group, in which only four patients experienced a one-degree reduction in hepatic steatosis attributable to lifestyle changes.
Insulin resistance, determined by measures of HOMA-IR, adiponectin, and leptin, was shown to be reduced by 15% in the tocotrienol group. Adiponectin and leptin are hormones that are critically secreted by adipose tissue. In the tocotrienol group, adiponectin levels increased by 44% and leptin decreased by 18%. In the placebo group, adiponectin levels increased by only 3% and leptin decreased by 3%.
The authors of the study concluded that “delta-tocotrienol supplementation for 24 weeks effectively improved biochemical markers of hepatocellular injury and steatosis in patiens with NAFLD,” and further, they remarked that “delta-tocotrienol might be considered as a therapeutic option in the management of patients with NAFLD.”
Dr. Barrie Tan, president of American River Nutrition, the makers of DeltaGold, said that the additional results coming from the 24 week study provided further substantiation of DeltaGold’s effect.
“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 said. “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 DeldaGold in NAFLD patients, and we look forward to sharing those results soon.
