Clinical Trials & Quality

Quality, Made in the USA

It may seem cliche 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 we are even working on upgrading it 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.

We also perform periodic testing for WADA banned substances.

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. It is suspected they used a non natural product and ferment it, and then somehow are allowed to label it Natural. They will not confirm their starting material is 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 3 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:

  • 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)

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.