BGG’s annatto tocotrienol production does not infringe American River Nutrition’s patents, concludes California court

10 Feb 2022 --- BGG World is celebrating a “favorable” outcome to the ongoing lawsuit filed by American River Nutrition (ARN) pertaining to annatto tocotrienols. This comes as ARN’s DeltaGold annatto-derived tocotrienol ingredient is found to improve glycemic control, including fasting glucose and glycosylated hemoglobin.

The lawsuit argued BGG had infringed a patent ARN held on a production process for annatto tocotrienols. Ultimately, the US District Court for the Central District of California’s final decision grants BGG’s motion for a summary judgment of non-infringement. 

“Patent litigations can be very expensive in the US, but as we were extremely confident in our position, we went through a three-year litigation. Now we can invest our money in a better way, including new clinical investigations on tocotrienols,” Yanmei Li, BGG’s global chief scientific officer, tells NutritionInsight.There are alpha, beta, gamma, delta molecules for both tocopherols and tocotrienols. 

Differentiation is crucial
Following the court’s decision, both parties have dismissed all claims and counterclaims in the case. 

“There will be no appeal by ARN of the summary judgment in BGG’s favor ending the litigation with a complete victory for BGG,” states BGG. 

Li adds that the company works in a competitive landscape, and differentiation is key to competing. 

“We have always been investing in R&D, and this proved to be once again a key reason for our success.”

The company’s production system can remove higher levels of contaminants and concentrate the tocotrienols to over 90% levels. With this technology, BGG can separate and purify each single compound into greater than 98% purity, thereby enabling pharmaceutical applications.

Hope for prediabetes
For the first time, DeltaGold has “unambiguously” been shown to improve primary and secondary outcomes in confirmed prediabetic subjects. 

The randomized trial found that it indicated “significant efficacy” on fasting blood glucose, glycated hemoglobin (HbA1c), insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) scores.

Over 12 weeks, 77 prediabetes patients received 300 mg per day of DeltaGold, which led to improved glycemic control and utilization. This was compared to a blinded and placebo group. 

Ultimately, HbA1c was reduced from 6.04 to 5.77%, inching further away from the 7% threshold at which conversion to Type 2 diabetes mellitus can become problematic. 

There was no decrease in HbA1c levels in the placebo group, which increased from 5.99 to 6.04%. In addition to a 4.3% improvement in fasting blood glucose, researchers found that weight, body mass index and waist circumference decreased in the tocotrienol group, whereas these increased slightly in the placebo group.

Secondary endpoints further strengthened tocotrienol benefits for prediabetic patients. Blood sugar utilization was supported by significant reductions in insulin (11.2%) and the HOMA-IR (15.1%) for patients taking annatto tocotrienols, while these biomarkers remained largely unchanged in the placebo group.Tocotrienols are derived from three major sources, including annatto, palm and rice.

Explaining discrepancies
Notably, early trials using different tocotrienol preparations to study similar parameters of metabolic syndrome did not work.

“The reason for this discrepancy in the results may be the purity and composition of the supplement used in these studies, indicating that only certain tocotrienol isoforms, like delta-tocotrienol, exhibit significant hypoglycemic activity,” note the researchers.

DeltaGold contains 90% delta- and 10% gamma-tocotrienol. These are part of the vitamin E family, which includes four tocopherols and four tocotrienols. 

Vitamin E’s supply chain has been under pressure, with ARN previously noting it can be difficult to source raw materials. 

Not all vitamin E is created equal
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, notes ARN. 

Dr. Barrie Tan, president of ARN, adds that studies into metabolic protection consistently underscored delta- and gamma-tocotrienol forms of vitamin E as the most potent for this application, with the absence of alpha-tocopherol being key. 

“This prediabetes trial compliments two Type 2 diabetes mellitus studies published in 2021, with DeltaGold correcting metabolic disturbances brought on by prediabetes and diabetes alike,” he adds.

Last month, a study also found that DeltaGold may be able to keep bone loss at bay in post-menopausal women, bringing the company a step closer to a structure-function claim. 

By Katherine Durrell