08.19.22
A recent study conducted at the Armed Forces Institute of Pathology in Pakistan, published in Complementary Therapies in Medicine, added further data to the existing body of evidence that shows tocotrienol benefits for the liver.
Results of the 48-week randomized, double-blind, active-controlled trial of the patented DeltaGold annatto-derived tocotrienol ingredient by American River Nutrition indicated significant efficacy on liver-related biomarkers, fatty liver index and HOMA-IR scores, and greater efficacy than alpha-tocopherol in reducing body weight and managing inflammation.
In the 48-week study of 100 NAFLD patients, DeltaGold tocotrienol and alpha-tocopherol were administered at dosages of 600 mg/day (300 mg twice daily) and 536 mg/day or 800 IU (268 mg twice daily), respectively, which led to decreased biochemical levels and metabolic factors associated with steatosis and pre-fibrosis. DeltaGold tocotrienol was a more effective anti-fatty liver agent, according to the study. All patients were advised to follow a lifestyle modification of regular physical activity and reduced fat and carb diet.
Study Details
Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is stored in the liver, and is most commonly associated with overweight, obesity, and metabolic syndrome. According to the Mayo Clinic, NAFLD affects approximately 80-100 million U.S. adults, and can transition to the more serious non-alcoholic steatohepatitis (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.
Based on clinical trials, physician experience, and decreased plasma levels of the vitamin found in NASH patients, alpha-tocopherol at a dose of 800 IU/day is recommended for non-diabetic steatohepatitis patients. The new study hypothesizes that due to tocotrienol’s antioxidant and anti-inflammatory properties, this vitamin E isomer may be more effective than alpha-tocopherol for those affected by fatty liver disease.
Among the most notable primary endpoints were the significantly greater reductions in weight, BMI, and waist circumference by tocotrienol compared to alpha-tocopherol. Tocotrienol was able to achieve the same weight-related drop in half the amount of time (24 weeks) as alpha-tocopherol, and at 48 weeks, weight loss, BMI and waist circumference reductions achieved with tocotrienol were 27%, 24%, and 24% greater than those achieved with alpha-tocopherol, respectively. Tocotrienol’s reduction of triglycerides was borderline significantly greater than that of alpha-tocopherol, resulting in a 16% drop at 48 weeks—28% better than what alpha-tocopherol was able to accomplish.
Secondary endpoints of the study looked at changes in inflammation, including interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha), hs-CRP, leptin, and adiponectin, while also testing patients for the degree of liver cell apoptosis.
With the exception of hs-CRP, which was reduced similarly by tocotrienol (38%) and alpha-tocopherol (33%), delta tocotrienol had significantly greater impacts on inflammatory markers in NAFLD patients. Tocotrienol reduction of IL-6 and TNF-alpha was 32% and 28% at 48 weeks, respectively, compared to 25% and 21% for alpha-tocopherol.
Both adiponectin and leptin are hormones that are secreted by adipose tissue. Adiponectin regulates glucose levels and fatty acid breakdown, whereas leptin is pro-angiogenic, pro-inflammatory, and chronically elevated in obesity. In the tocotrienol group, adiponectin levels increased by 32%, whereas leptin decreased by 14%. In comparison, adiponectin in the alpha-tocopherol group increased by only 21%, with leptin decreasing 10%.
Notably, steatosis-induced liver cell death, marked by levels of CK18-M30, was decreased following supplementation with delta-tocotrienol (18%) more so than alpha-tocopherol (12%) in the first 24 weeks, and reached a reduction of 23% and 15% at 48 weeks, respectively. Both tocotrienol and alpha-tocopherol resulted in similar decreases of liver injury enzymes ALT, AST, and ALP, fibrosis markers FIB-4, APRI, and NFS, and oxidative stress marker MDA. No side effects were reported following the consumptions of supplements.
The study authors noted that “delta-tocotrienol was more potent than alpha-tocopherol in reducing body weight, inflammation, and hepatocyte apoptosis associated with NAFLD,” further remarking that “thus, delta-tocotrienol supplementation might be considered as a preferred therapeutic option […] in the management of patients with NAFLD.”
Commenting on the research, Barrie Tan, president of American River Nutrition said that “30% of the adult population worldwide has NAFLD, a tragedy the medical community refers to as ‘Population Code Blue’.” Tan pointed to earlier placebo-controlled trials with similar positive results that add to the strong proof of DeltaGold’s effect in fatty liver disease.
“This is the first time delta-tocotrienol was compared head-to-head with alpha-tocopherol, and the results did not disappoint,” Tan added. “Not only did delta-tocotrienol supplementation lead to superior sustained weight loss of > 10 pounds in obese NAFLD patients, but it was also significantly better at improving inflammation and preventing liver cell death than the alpha-tocopherol form of vitamin E commonly recommended by physicians. With the significant advantages of tocotrienol over tocopherol for weight loss and inflammation, the time has come to update the vitamin E guidance for NAFLD patients.”
Results of the 48-week randomized, double-blind, active-controlled trial of the patented DeltaGold annatto-derived tocotrienol ingredient by American River Nutrition indicated significant efficacy on liver-related biomarkers, fatty liver index and HOMA-IR scores, and greater efficacy than alpha-tocopherol in reducing body weight and managing inflammation.
In the 48-week study of 100 NAFLD patients, DeltaGold tocotrienol and alpha-tocopherol were administered at dosages of 600 mg/day (300 mg twice daily) and 536 mg/day or 800 IU (268 mg twice daily), respectively, which led to decreased biochemical levels and metabolic factors associated with steatosis and pre-fibrosis. DeltaGold tocotrienol was a more effective anti-fatty liver agent, according to the study. All patients were advised to follow a lifestyle modification of regular physical activity and reduced fat and carb diet.
Study Details
Non-alcoholic fatty liver disease (NAFLD) occurs when excess fat is stored in the liver, and is most commonly associated with overweight, obesity, and metabolic syndrome. According to the Mayo Clinic, NAFLD affects approximately 80-100 million U.S. adults, and can transition to the more serious non-alcoholic steatohepatitis (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.
Based on clinical trials, physician experience, and decreased plasma levels of the vitamin found in NASH patients, alpha-tocopherol at a dose of 800 IU/day is recommended for non-diabetic steatohepatitis patients. The new study hypothesizes that due to tocotrienol’s antioxidant and anti-inflammatory properties, this vitamin E isomer may be more effective than alpha-tocopherol for those affected by fatty liver disease.
Among the most notable primary endpoints were the significantly greater reductions in weight, BMI, and waist circumference by tocotrienol compared to alpha-tocopherol. Tocotrienol was able to achieve the same weight-related drop in half the amount of time (24 weeks) as alpha-tocopherol, and at 48 weeks, weight loss, BMI and waist circumference reductions achieved with tocotrienol were 27%, 24%, and 24% greater than those achieved with alpha-tocopherol, respectively. Tocotrienol’s reduction of triglycerides was borderline significantly greater than that of alpha-tocopherol, resulting in a 16% drop at 48 weeks—28% better than what alpha-tocopherol was able to accomplish.
Secondary endpoints of the study looked at changes in inflammation, including interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha), hs-CRP, leptin, and adiponectin, while also testing patients for the degree of liver cell apoptosis.
With the exception of hs-CRP, which was reduced similarly by tocotrienol (38%) and alpha-tocopherol (33%), delta tocotrienol had significantly greater impacts on inflammatory markers in NAFLD patients. Tocotrienol reduction of IL-6 and TNF-alpha was 32% and 28% at 48 weeks, respectively, compared to 25% and 21% for alpha-tocopherol.
Both adiponectin and leptin are hormones that are secreted by adipose tissue. Adiponectin regulates glucose levels and fatty acid breakdown, whereas leptin is pro-angiogenic, pro-inflammatory, and chronically elevated in obesity. In the tocotrienol group, adiponectin levels increased by 32%, whereas leptin decreased by 14%. In comparison, adiponectin in the alpha-tocopherol group increased by only 21%, with leptin decreasing 10%.
Notably, steatosis-induced liver cell death, marked by levels of CK18-M30, was decreased following supplementation with delta-tocotrienol (18%) more so than alpha-tocopherol (12%) in the first 24 weeks, and reached a reduction of 23% and 15% at 48 weeks, respectively. Both tocotrienol and alpha-tocopherol resulted in similar decreases of liver injury enzymes ALT, AST, and ALP, fibrosis markers FIB-4, APRI, and NFS, and oxidative stress marker MDA. No side effects were reported following the consumptions of supplements.
The study authors noted that “delta-tocotrienol was more potent than alpha-tocopherol in reducing body weight, inflammation, and hepatocyte apoptosis associated with NAFLD,” further remarking that “thus, delta-tocotrienol supplementation might be considered as a preferred therapeutic option […] in the management of patients with NAFLD.”
Commenting on the research, Barrie Tan, president of American River Nutrition said that “30% of the adult population worldwide has NAFLD, a tragedy the medical community refers to as ‘Population Code Blue’.” Tan pointed to earlier placebo-controlled trials with similar positive results that add to the strong proof of DeltaGold’s effect in fatty liver disease.
“This is the first time delta-tocotrienol was compared head-to-head with alpha-tocopherol, and the results did not disappoint,” Tan added. “Not only did delta-tocotrienol supplementation lead to superior sustained weight loss of > 10 pounds in obese NAFLD patients, but it was also significantly better at improving inflammation and preventing liver cell death than the alpha-tocopherol form of vitamin E commonly recommended by physicians. With the significant advantages of tocotrienol over tocopherol for weight loss and inflammation, the time has come to update the vitamin E guidance for NAFLD patients.”
