70 product launches in just over 2 years

New clinical data opening doors for Nitrosigine beyond sports nutrition

By Stephen Daniells contact

- Last updated on GMT

Sports, cognitive function and more. Image © iStock/zamuruev
Sports, cognitive function and more. Image © iStock/zamuruev

Related tags: Sports nutrition, Nutrition, Amino acid, Clinical trial

Having quickly established its credentials in the sports nutrition space, positive results in recent clinical trials are creating new opportunities for Nutrition 21’s Nitrosigine in the cognitive health sector.

Consumer awareness for the inositol-stabilized arginine silicate ingredient is growing fast, based on the 70-plus launches for Nitrosigine-containing products in under 2.5 years in the US and Canada, said Jim Kahn, Nutrition 21’s executive director of sales.

The company has run consumer marketing campaign to boost awareness, and developed co-promotion programs to support its brand-marketing customers that helps to drive sales of their pre-workout products, he said.

“We expect to see some interesting product launches this year”

New opportunities are now opening up in the cognitive health sector, with data from two double-blind placebo-controlled crossover studies​ indicating that Nitrosigine may boost cognitive performance in tests requiring mental flexibility, processing speed and executive functioning (Nutrients​, 2016, 8​(11), 736).

“The newest published studies on Nitrosigine opened the door beyond being a top pre-workout, muscle enhancement supplement, to show multiple benefits for cognitive function; and we are pleasantly surprised to see growing interest in this category for both sports nutrition and non-sports nutrition categories,” ​Joe Weiss, President of Nutrition 21, told us.

“Our initial discussions with brand marketers regarding the Nitrosigine data we have on cognitive support have been very encouraging, so we expect to see some interesting product launches this year,” ​added Weiss.

Science & innovation

Development of the ingredient started with a look at opportunities around the amino acid arginine, explained James Komorowski MS, CNS, the company’s VP of scientific and regulatory affairs. “As we looked at the arginine category and more importantly the lack of innovation in the area of nitric oxide (NO) production, a key factor for enhanced blood flow, our scientific team developed a patented complex of bonded arginine silicate with unique synergistic benefits,”​ he said.

“Results from a recent ​in vitro study showed Nitrosigine boosted NO production five times more than other ingredients,” ​added Komorowski.

Specifically, Nitrosigine led to higher NO levels compared to arginine AKG, L-arginine, agmatine sulfate, L-citrulline, and L-citrulline malate (data presented at the International Society of Sports Nutrition 13th Annual Conference last year).​ The study also showed that Nitrosigine was the only one to increase NO production significantly compared to control (see figure 1).

Figure 1. Nitrosigine vs arginine AKG, L-arginine, agmatine sulfate, L-citrulline, and L-citrulline malate. Image: Nutrition 21

In addition, data presented at the ISSN meeting showed that the bonded arginine silicate complex was more effective at increasing serum arginine and silicon levels compared to equivalent doses of arginine, silicon and inositol as individual components.

“Nitrosigine is fast acting and long lasting, increasing arginine levels in as quickly as 15 minutes and lasting up to 6 hours – after just a single dose,” ​said Komorowski. “It can provide enhanced arginine levels through an entire workout. With continued use, NO levels build over time.”

“The body of research supporting Nitrosigine has led to numerous discoveries and application opportunities within the sports nutrition and mainstream consumer nutritional product categories.”


In addition to the science, the company has achieved regulatory recognition for the safety of the ingredient: FDA accepted Nitrosigine as a New Dietary Ingredient (NDI)​ and Nitrosigine has self-affirmed Generally Recognized As Safe (GRAS) status​ at the level of 1,500 mg per day for use in nutritional bars and beverages.

The company is now working on obtaining EFSA approval in the EU and anticipates approval by mid-year, Weiss told NutraIngredients-USA.

So what’s next for the ingredient? “Nitrosigine is such a versatile compound with so many varied health benefits that it provides plenty of opportunities for clinical research and new applications for introduction to the marketplace,”​ said Weiss.

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