Clinical Trials & Quality

Quality, Made in the USA

It may seem cliché when a company rattles off "Made in the USA" and all of their GMP measures. So let me explain our commitment in details.


1) Made in the USA.
Many companies will literally buy racemic ketone salts from China, place them in a tub in the USA, and label it "Made in the USA" or some will use the "with foreign and domestic ingredients", which usually means 99% of the product is from China, and maybe they throw in 1 thing from the USA. I don't know how a customer is able to decipher.

Our ketone ester is actually manufactured, as in actually made in the USA. We own our own dedicated equipment that is just used to make ketone ester. The facility is cGMP and if necessary (for a large clinical trial) can be upgraded to a pharmaceutical grade facility. The ketone ester undergoes dozens of 3rd party testing to ensure each batch is of the highest quality. No other ketone ester comes close to the quality of our drink.

Other ketone ester companies are merely front end marketing companies. They have to order from an overseas manufacturer and rely on their quality assurance. The problem with that is it is very easy to make short cuts and manipulate the data to appear as if it is of high quality. Again we make ours, and if it doesn't meet spec it gets further purified.

Each batch of KE4, KE1 and Snakewater are 3rd party batch tested for WADA compliance. Certificate is available upon request.

2) All Natural
Wikipedia is wrong. Somebody years ago stated that ketone salts were natural and ketone esters were synthetic, and Wikipedia copied that. Most ketone salts are racemic and far from natural. They are synthetically made in China from petroleum. There are some that are mostly non racemic (80% D form), which is better, but still not even close to an all natural product. Even the few that offer 100% non-racemic ketone salts may not be "all natural" even if they claim to be. Note that they don't say "plant based". They use a non natural (oil based) starting product and ferment it, and then somehow are allowed to label it Natural. 
While it may have been the case years ago with ketone esters, they are not synthetic. They are an all natural product. Ironically it starts with sugar and through multiple fermentation processes (think beer, wine), and distillation to isolate the ketone ester compound, it remains natural along the way.

KetoneAid Chosen for several Clinical Trials

Our product KE4 has been chosen for multiple clinical trials. The first published paper focused on wind-sprints, but by our added recommendation, they tested the brain. Thank goodness, because they found an amazing discovery. (see paper).

Current Trials:

  • Effects of Ketosis on Muscle Kinetics and Signaling During Critical Illness (see trial)
  • Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure (see trial)
  • Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Cardiogenic Shock (see trial)
  • Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19 (see trial)
  • Treatment With the Ketone Body 3-hydroxybutyrate [Ketone Ester] in Patients With Acute Heart Failure (see trial note they switched to KetoneAid)
  • More not listed here for legal compliance reasons. Search for KetoneAid

Two Ketone Ester Clinical Trials focused on the Brain

This blog post goes into 2 clinical trials using ketone ester. KetoneAid supplied 1 of the 2 trials. Blog Post here.

Seeking Principal Researchers for more Clinical Trials

Several clinical trials are at various stages, all supplied by KetoneAid.
While our website may focus on sports, KetoneAid is very interested in collaborating with Principal Investigators to further test the boundaries of our Ketone Ester. Please contact us.