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CLINICAL TRIAL article

Front. Neurol.
Sec. Experimental Therapeutics
Volume 15 - 2024 | doi: 10.3389/fneur.2024.1483876
This article is part of the Research Topic Exploring Chronic Fatigue: Neural Correlates, Mechanisms, and Therapeutic View all 3 articles

RESTORE ME: A RCT of Oxaloacetate for Improving Fatigue in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

Provisionally accepted
Alan Brian Cash Alan Brian Cash 1*Suzanne D Vernon Suzanne D Vernon 2Candace Rond Candace Rond 2Saeed Abbaszadeh Saeed Abbaszadeh 2Jen Bell Jen Bell 2Brayden Yellman Brayden Yellman 2David Kaufman David Kaufman 3
  • 1 Terra Biological LLC, San Diego, United States
  • 2 Bateman Horne Center, Salt Lake City, Utah, United States
  • 3 Center for Complex Disease, Mountain View, CA, United States

The final, formatted version of the article will be published soon.

    The energy metabolite oxaloacetate is significantly lower in the blood plasma of ME/CFS subjects. A previous open-label trial with oxaloacetate supplementation significantly reduced ME/CFS fatigue.In a follow-on trial, 82 ME/CFS subjects were enrolled in a 3-month randomized double blinded controlled trial using 2,000 mg oxaloacetate or control/day. The primary endpoints were safety and a reduction in fatigue from baseline. Secondary and exploratory endpoints reviewed functional capacity, and general health status.Results: Anhydrous enol-oxaloacetate (oxaloacetate) was well tolerated at the doses tested. Oxaloacetate significantly lowered fatigue from baseline by >25%, whereas the control group was not significant at ~10% reduction. Intergroup analysis of oxaloacetate and control measured shifted fatigue to lower levels in the oxaloacetate group (P= 0.0039), but with no significant shift in the control group. The oxaloacetate group had a higher percentage of subjects achieve a > 25% reduction in fatigue compared to the control group (P< 0.05). A subset of subjects that comprised 40.5% of the oxaloacetate group were "Enhanced Responders" with a 63% average fatigue reduction. Both physical and mental fatigue were improved by oxaloacetate.Oxaloacetate is well-tolerated and helps to reduce fatigue in ME/CFS.

    Keywords: chronic fatigue syndrome, ME/CFS, Oxaloacetate, Fatigue, fatigue treatment, ME/CFS Treatment, Chronic Fatigue Treatment, Clinical Trial ME/CFS

    Received: 20 Aug 2024; Accepted: 02 Oct 2024.

    Copyright: © 2024 Cash, Vernon, Rond, Abbaszadeh, Bell, Yellman and Kaufman. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Alan Brian Cash, Terra Biological LLC, San Diego, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.