A new clinical trial assessing whether an oral ketone beverage is safe and well-tolerated during moderate-intensity exercise and whether it is able to raise blood ketones to normal levels in patients with long chain fatty acid oxidation disorders (LCFAODs) has just opened.
The early phase 1 trial aims to recruit 5 participants with a confirmed diagnosis of very long-chain acyl-CoA dehydrogenase, long-chain 3-hydroxy-acyl-CoA dehydrogenase, trifunctional protein, or carnitine palmitoyltransferase 2 deficiency, aged 18 years and older at Oregon Health & Science University in Portland.
Participants will either receive the ketone beverage or an isocaloric maltodextrin beverage as a placebo and then, 20 minutes later, engage in moderate-intensity exercise on a treadmill for 45 minutes. This will be repeated again 2 days later when patients will consume the opposite beverage than the one they consumed the first time round before starting the exercise.
Read more about the types of LCFAOD
The primary outcome measures of the trial are the incidence, type, severity, and causal relationship of adverse events, any abdominal discomfort, decreased appetite, gastric reflux, nausea, diarrhea, or headache. Secondary outcome measures are the levels of lactate in the blood, blood pressure, perceived exertion, respiratory exchange ratio, and heart rate.
The trial is not yet open for recruitment. It will run from August 1, 2022, to July 31, 2023.
The ketone beverage contains a mix of sodium, calcium, and magnesium salts of D-beta-hydroxybutyrate with nicotinamide riboside chloride, flavors, and stevia sweetener. The control beverage contains maltodextrin with flavors and stevia sweetener.
There is currently no cure for any type of LCFAOD. Treatment consists of avoiding long periods of fasting and intense exercise, as well as a strict nutritional plan of a diet low in long-chain fatty acids supplemented with medium-chain triglyceride.
Oral ketones and exercise among patients with long-chain fatty acid oxidation disorders. US National Library of Medicine. Updated June 9, 2022. Accessed June 21, 2022.