Clinical Study: Relationships between fatigue, cognitive function, and upright activity in a randomized trial of oxaloacetate for myalgic encephalomyelitis/chronic fatigue syndrome

Frontiers in Neurology, the third most cited open access journal in clinical neurology with an Impact Factor of 3.552, peer reviewed and published the results of an 82 person Randomized Clinical Trial (RCT) of oxaloacetate for ME CFS fatigue conducted at the Bateman Horne Center.

• This study was a randomized, double blinded clinical trial performed at the Bateman Horne Center in Salt Lake City, Utah. The Bateman Horne Center is a non profit Center of Excellence improving lives impacted by Myalgic encephalomyelitis chronic fatigue syndrome (ME CFS) and related comorbidities.
• The clinical trial used Oxaloacetate CFS (500 mg anhydrous enol oxaloacetate capsules) with 2 capsules being taken with breakfast and 2 capsules being taken with lunch each day during the 3 month trial period in a single dosage level.
• The RCT confirms the ability of the medical food Oxaloacetate CFS to reduce fatigue in ME CFS patients by greater than 25 percent on average. The improvement in fatigue lasted at least the length of the 3 month study.
• Interestingly, in a sub group of 40.5 percent of the patients, there was greater than 25 percent improvement in fatigue, with an average fatigue improvement of 63 percent, indicating that for these patients, oxaloacetate is the right key to unlock fatigue for this sub patient group. Metabolomic analysis of the blood samples taken during the study are underway at Stanford University and University of Melbourne to ascertain key features of why this subgroup performed so well.

Abstract

Background

The energy metabolite oxaloacetate is significantly lower in the blood plasma of ME CFS subjects. A previous open label trial with oxaloacetate supplementation demonstrated a significant reduction in myalgic encephalomyelitis chronic fatigue syndrome (ME CFS) related fatigue.

Methods

In this follow up trial, 82 ME CFS subjects were enrolled in a 3 month randomized, double blinded, controlled study, receiving either 2,000 mg of oxaloacetate or control per day. The primary endpoints were safety and reduction in fatigue from baseline. Secondary and exploratory endpoints included functional capacity and general health status.

Results

Anhydrous enol oxaloacetate (oxaloacetate) was well tolerated at the tested doses. Oxaloacetate significantly reduced fatigue by more than 25 percent from baseline, while the control group showed a non significant reduction of approximately 10 percent. Intergroup analysis showed a significant decrease in fatigue levels in the oxaloacetate group (p = 0.0039) with no notable change in the control group. A greater proportion of subjects in the oxaloacetate group achieved a reduction in fatigue greater than 25 percent compared to the control group (p < 0.05). Additionally, 40.5 percent of the oxaloacetate group were classified as enhanced responders, with an average fatigue reduction of 63 percent. Both physical and mental fatigue improved with oxaloacetate supplementation.

Conclusion

Oxaloacetate is well tolerated and effectively helps reduce fatigue in ME CFS patients.

Clinical trial registration

https://clinicaltrials.gov/study/NCT05273372

Keywords

chronic fatigue syndrome, ME CFS, oxaloacetate, fatigue, fatigue treatment, ME CFS treatment, chronic fatigue treatment, clinical trial ME CFS