Annatto Tocotrienol Improves Glycemic Control in Patients with Type 2 Diabetes Mellitus

Hadley, Massachusetts (May 18, 2021) – Delta-tocotrienol from annatto improved glycemic control, inflammation, and oxidative stress, suggests a published clinical study in patients diagnosed with type 2 diabetes mellitus (T2DM).

A recent trial published in Phytotherapy Research is the first to show tocotrienol benefits for insulin resistance and overall blood sugar control. 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 fasting blood glucose, glycated hemoglobin (HbA1c), insulin, HOMA-IR scores, and various inflammation and oxidative stress markers.

In the 24-week study of 110 T2DM patients, DeltaGold tocotrienol was administered at a dosage of 250mg/day, which led to improved glycemic control accompanied by reduced inflammation and oxidative stress, and was further confirmed by modified miRNA expression. This was compared to a blinded and placebo group. All patients were advised a lifestyle modification of regular physical activity and continued on their typical hypoglycemic agents without insulin usage.

Study details

Type 2 diabetes mellitus (T2DM) occurs when cells respond poorly to insulin, a key regulator of blood sugar. The resulting insulin resistance prevents sugar from entering cells, causing high blood sugar levels that eventually lead to serious health conditions, including cardiovascular, neurological, eye, and kidney diseases. According to the CDC, T2DM affected approximately 34 million US adults, but an additional estimated 88 million adults had prediabetes in 2018. In 2017, diabetes was the 7th leading cause of death in the US, and the total estimated annual cost of diabetes was $327 billion. Pharmacological treatments for T2DM are abundant, but carry sometimes serious side effects. It is therefore desirable to reduce the need for hypoglycemic agents, and supplemental natural alternatives can help.

As its primary endpoint, the 24-week trial explored whether DeltaGold tocotrienol, in addition to hypoglycemic agents, diet, and exercise, could improve glucose control while reducing inflammation and oxidative stress. HbA1c, a long-term stable measure of blood sugar control, was successfully reduced from 8.3% to 7.8%, approaching the 7% threshold at which diabetes complications can be delayed or prevented. There was no change in HbA1c levels in the placebo group, which remained at 8.4%. In addition to improved glucose control, researchers found that inflammation, marked by high-sensitivity C-reactive protein (hs-CRP), was reduced by 10%, whereas these levels increased in the placebo group. Oxidative stress was also lowered significantly, with biomarker malondialdehyde (MDA) dropping by 9% without change in the placebo group.

Secondary endpoints further strengthened tocotrienol benefits for T2DM patients. Blood sugar management was supported by significant reductions in fasting blood glucose (6.8%), insulin (7.6%), and the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR; 13.1%) for patients taking annatto tocotrienols, while these biomarkers remained largely unchanged in the placebo group.

Notably, triglyceride levels, which are typically elevated before hyperglycemia sets in, dropped by a significant 10.3%, with only a 0.9% change noted in the placebo group. Although the study was not designed to monitor hypercholesterolemia, total cholesterol and LDL cholesterol levels in the tocotrienol group were reduced by 7.2% and 8.5%, respectively, with little to no change in the placebo group.

Mirroring results of other clinical trials conducted with annatto-derived DeltaGold tocotrienol, supplemented patients, but not the placebo group, saw significant reductions in inflammatory markers, with IL-6 and TNF-alpha dropping 15.9% and 13.7%, respectively.

Further cementing tocotrienol’s functional advantage for T2DM patients, the researchers showed 2-3-fold modifications in microRNAs associated with diabetes, inflammation, and oxidative stress. Lauding tocotrienol as a long-term control and prevention measure for diabetes, the researchers noted that “delta-tocotrienol in addition to oral hypoglycemic agents improved glycemic control, inflammation, oxidative stress, and miRNA expression in T2DM without any adverse effect.”

Commenting on the research, Dr. Barrie Tan, President of American River Nutrition said that “for the first time, tocotrienol has been shown to reduce functional insulin secretion and successfully manage blood sugar via multiple avenues, thereby improving T2DM hyperglycemic control.” Pondering why similar studies in the past were unable to show such impressive results, Tan says the unmatched presence of potent delta- and gamma-tocotrienol isomers and absence of alpha-tocopherol in DeltaGold from annatto are responsible for the superior benefits. Adds Tan, “it is well-known through previous clinical trials that tocopherol-free tocotrienol controls lipidemia, inflammation, and oxidative stress. Seeing these benefits extend to diabetes is not entirely unexpected, but remarkable nonetheless.”

Supplement details

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: Phytotherapy Research
doi: 10.1002/ptr.7113
Effects of delta-tocotrienol supplementation on Glycemic Control, oxidative stress, inflammatory biomarkers and miRNA expression in type 2 diabetes mellitus: A randomized control trial
Authors: Mahjabeen, W, Khan DA, Mirza, SA, Pervez, MA

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.

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