NAI founder and CEO: ‘This is an interesting time in our company’s history’

Beta-alanine has been a staple in pre-workout supplements for decades, with research linking it to improvements in exercise and cognitive performance.

A few examples include a 2014 study which linked the ingredient to benefits for both trained and untrained adults​​, as well as a study published last year, which linked beta-alanine to inhibited declines in executive brain function caused by post-endurance exercise fatigue in adults over the age of 50​​.

In both the US and the global market, the branded form of beta-alanine called CarnoSyn, manufactured and distributed by California-headquartered Natural Alternatives International, is protected by a suite of patents for its use in performance nutrition.

More recently, new patents protect a slow-release version of CarnoSyn, developed for use in products beyond sports nutrition characterized by the lack of tingling (also known as paresthesia) that comes with ingesting traditional beta-alanine.

In June, Natural Alternatives International’s CarnoSyn was awarded the NutraIngredients-USA Sports Nutrition Ingredient of the Year, impressing the judges for its strong suite of scientific backing.

They were particularly impressed with the end points of the studies that related directly to sports nutrition benefits such as improved endurance, strength increases, better recovery from intensive exercise, etc. as opposed to endpoints that might be tangentially related to sports benefits, such as a high antioxidant capacity for dealing with post-exercise inflammation.

We caught up with Mark LeDoux, CEO and founder of Natural Alternatives International, to learn a bit more about the ingredient’s history, and how the company will bring it forward.

The following has been edited for clarity and length:​

CarnoSyn was first developed for use in sports nutrition, if I understand that correctly. Can you tell me a little bit about CarnoSyn’s history?​

I started the company as an idea to identify natural alternatives to what I consider to be dangerous drugs. I started in 1980. I have been doing this for almost 40 years. My focus was in applying scientific research to evaluate natural substances that may help the human body take care of itself without harmful side-effects.​

The original premise of CarnoSyn, we felt very strongly that the preliminary research demonstrated that ingesting a certain number of grams per day, I think it’s 6.4 grams, would really move the needle in establishing a reserve in the human striated muscle of the dipeptide known as carnosine. ​

By establishing a pool of carnosine, when you are stressing striated muscle through endurance training or endurance athletics, what this level of carnosine is able to achieve is to buffer lactic acid which is generated through the constant firing of muscle fibers.​

By buffering it, it allows the athlete to exercise between 10 and 15% longer before you reach exhaustion. That was the primary wow finding—we found it in rowers, we found it in long-distance runners. Because of the original patents that were issued on this, it became the pre-eminent component of pre-workout materials.​

I’ve seen several patents protecting its use in healthy aging products. How has its usage in formulations and product development changed over time?​

In certain circumstances, people who take large amounts of beta-alanine can experience a tingle. In certain cases people think ‘oh, yeah, that’s working.’ ​

We started working on a sustained-release approach—my theory was that if we were able to delay the release in the gut of beta-alanine, we can greatly reduce or eliminate the incidence of paresthesia [the tingle].​

Our focus is now on that segment of the population. Think healthy aging for example—look at the demographics around the world, aging is a more robust demographic than athletes or weekend warriors. The fact that this sustained-release model does not lead to that tingling really bodes well to somebody in their 50s or 60s—they don’t want to feel like they’re having a niacin flush.​

The healthy aging market, we think its 10 times bigger than the sports nutrition market.​

What do you think is the most pressing issue for CarnoSyn today? In other words, as CEO, what keeps you up at night?​

This is an interesting time in our company’s history. We succeeded in March this year in securing a New Dietary Ingredient notification, saying that the FDA has reviewed our submission data, or toxicology data and so on, saying that this is an appropriate substance​.

[Editor’s note: In this context, ‘securing’ means that NAI received FDA’s acknowledgment of receipt of NAI’s submission and has no objections.]

That means all these other materials that do not come from us, and don’t go through our quality control standards, are technically adulterated. So we’re actually mystified that we haven’t seen more adoption of our NDI product.​

We’re working with the FDA to come up with an intelligent way to inform the consumers as well as the industry that if you’re not using CarnoSyn beta-alanine with an NDI status, you’re conceivably consuming an adulterated substance.​